Meibomian Gland DysfunctionNCT04052841
Morphological Analysis of Meibomian Glands
A study testing Thermal pulsation, Intense pulsed light therapy and Manual warm compresses in people with Meibomian Gland Dysfunction, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 2 sites in China.
Trial summary
An automated quantitative meibomian gland analyzer based on all kinds of infrared meibomian gland images was develop to obtain more detail in meibomian gland, including width, length, area, signal intensity correlated to the quality of meibum, deformation index and ratio of area of each visible specific gland. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Meibomian Gland Dysfunction
- What is being tested?
- Thermal pulsation, Intense pulsed light therapy and Manual warm compresses
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesChina
- Study dates
- 12 Oct 2020to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of MGD: The diagnosis of MGD was based on an altered quality of expressed secretions and/or decreased or absent expression.
- Patients without ≥2/3 Meibomian glands atrophy.
- Fitzpatrick skin type 1-4.
- Negative history or condition of ocular or systemic illness based on evaluation by a research physician.
- General Exclusion Criteria:
- Patients and healthy volunteers with ocular allergies, trauma, contact lens wear, continuous medications usage such as tretinoin, isotretinoin, antidepressant medications, photosensitive drugs, glucocorticoids and immunomodulators, or have used them within one month.
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- Patients and healthy volunteers who have a history of ocular surface surgery.
- Patients and healthy volunteers who have active ocular surface infection or have suffered from ocular surface infection within one month.
- Patients and healthy volunteers who have endophthalmitis or a medical history of endophthalmitis.
- Patients and healthy volunteers who have a medical history of viral keratitis infection.
- Women who are pregnant, planning to become pregnant during the course of the study or breast-feeding (women of child-bearing age will be asked by the physician).
- Meibography images were blurred or with obvious tarsus folds, incomplete exposure and large hyperreflective area.
- Patients and healthy volunteers who are not suitable for the trial as determined by investigators.
Who cannot join
- Patients have abnormalities of ocular surface function or eyelid function, or presence of precancerous lesions, cancer or pigmentation in the eyelid area.
- Patients who have plans to receive ocular surgeries (e.g., cataract, myopic refractive surgery) within 6 months.
- Patients who have been treated with lacrimal punctum embolization within one month.
- Patients with disease that could lead to ADDE, such as Sjogren syndrome and a lacrimal gland abnormality.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Zhongshan Ophthalmic Center, Sun Yat-Sen University
Guangzhou, Guangdong, 510080
Saiqun Li, M.D., Ph.D., 86-013642710612, 123213197@qq.com
Jin Yuan, M.D., Ph.D.
- Recruiting
Deng Yuqing
Guangzhou, 510060
Yuqing Deng, MD, 18120557291, 15927646647@163.com
Jin Yuan, PHD
About this study
Official title: Automated Morphological Analysis of Meibomian Glands
An automated quantitative meibomian gland analyzer based on all kinds of infrared meibomian gland images was develop to obtain more detail in meibomian gland, including width, length, area, signal intensity correlated to the quality of meibum, deformation index and ratio of area of each visible specific gland. The purpose of this study is present as separate sections the following points: (1) to compared the detailed characteristics of meibomian glands in normal subjects, Meibomian gland dysfunction (MGD) patients by the automated quantitative analyzer; (2) to identify the inter-examiner and intra-examiner repeatability of the new technique; (3) to explore the correlation among morphological and functional parameters of meibomian gland and risk factors，clinical symptoms and signs; (4) to explore the sensitivity and specificity of meibomian gland morphological and functional parameters in MGD diagnosis. (5) using morphological and functional parameters as new assessment of MGD severity and efficacy indicators for treatment.
Read the detailed description
Meibomian glands are essential for maintaining ocular surface health and integrity secrete various lipid components to forms a lipid layer to prevent excessive tear evaporation. Functional disorders of the meibomian glands, referred to today as meibomian gland dysfunction (MGD), are increasingly recognized as a high incidence disease commonly characterized by terminal duct obstruction and/or abnormal glandular secretion, often results in ocular surface epithelium damage, chronic blepharitis and dry eye disease that significantly reduces quality of life. A wide variation of the prevalence of MGD were reported from 0.39% to 69.3%, which is likely due to lack of diagnostic methods. To identify which clinical features are likely to be predictive of progressive disease in MGD may indicate the early diagnosis and proper treatment strategies.
Histologic section through the normal meibomian glands and the obstructed human meibomian gland revealed that obstruction of orifice in MGD could lead to dilation of the central duct, damage of the secretory meibocytes and finally result in atrophy of dilated meibomian glands and glands drop-out. It was thus be accepted that detailed changes of meibomian glands morphology are key signs to diagnose and evaluate the severity of MGD. The detailed changes including dilation, distortion, shortening and loss of visualisation of glands which can be directly observed and visual assessment by the developed of non-contact meibomian gland infrared imaging technology. Quantitative evaluations of meibomian glands were obtain by developing imaging processing techniques. The most common use is the image editing software Image J (National Institute of Health; http://imagej.nih.gov/ij) which can identify the gland region on the image manually by the users and may lead to inter-observer variability. Koh et al., first applied original algorithms to automatically analysed gland loss in meibography images with a manually pre-processing. Reiko et al., then develop an objective and automatic system to measure the meibomian gland area. However, the existing methods of meibomian gland analysis have been limited to clinical use where large number of images needs to be analyzed efficiently due to the inter-observer variability or time-consuming process.
Meanwhile, the existing quantitative morphological parameters obtain by those imaging processing techniques, including percentage of MG drop-out and gland atrophy area, were suggested to not only be advanced stages or terminal changes in MGD, but also occurs as an age-related atrophic process. The early findings of MGD induced by the primary pathologic obstruction including degenerative gland dilation, irregularly shapes of gland and change of meibum quality are still difficult to be evaluated automatically and quantitively from the image. Moreover, the meibomian gland drop-out is still an approximate assessment without specific pattern. Whether the atrophy or loss occur in upper or lower eyelids, central, distal or proximal, total loss of gland or partial loss of gland has the greatest effect on the pathology progress of MGD will be important to identify. Thus, a comprehensive analysis technique to automatically detect multi-information of meibomian gland morphology will benefit the future early diagnosis and management of MGD.
Recently, an automated quantitative meibomian gland analyzer based on all kinds of infrared meibomian gland images was develop to obtain more detail in meibomian gland, including width, length, area, signal intensity correlated to the quality of meibum, deformation index and ratio of area of each visible specific gland. The purpose of this study is present as separate sections the following points: (1) to compared the detailed characteristics of meibomian glands in normal subjects and MGD patients by the automated quantitative analyzer; (2) to identify the inter-examiner and intra-examiner repeatability of the new technique; (3) to explore the correlation among morphological and functional parameters of meibomian gland and risk factors，clinical symptoms and signs; (4) to explore the sensitivity and specificity of meibomian gland morphological and functional parameters in MGD diagnosis. (5) using morphological and functional parameters as new assessment of MGD severity and efficacy indicators for treatment.
- Conditions
- Meibomian Gland Dysfunction
- Being tested
- Thermal pulsation, Intense pulsed light therapy, Manual warm compresses
- Medical subject headings
- Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal pulsationProcedure or surgery
Participants underwent a single LipiFlow® thermal pulsation system (TearScience Inc., Morrisville, NC,USA) treatment on the first visit: after lid hygiene with wet cotton swabs(OCuSOFT, Inc., Texas, USA) and instillation of anesthetic eye drops (Alcaine, proparacaine hydrochloride 0.4 ml/2mg) in both eyes, sterile eye cups were placed on to the conjunctival sac as instructed by the manufacturer, after 12 minutes of upper and lower palpebral conjunctival surfaces heat while simultaneously graded pulsatile pressure applying, eye cups were removed slightly.
Intense pulsed light therapyProcedure or surgery
Lid hygiene with wet cotton swabs(OCuSOFT, Inc., Texas, USA) before treatment. Intense pulsed light (IPL) with a range of wavelength (570 or 620 nm) was performed every 3 weeks，3 times in total (0, 3w, 6w). 10 pulses were transmited from one tragus through nose to the other tragus was a single pass, each treatment needed to do 2 passes. Manual lid massage was done after per IPL treatment.
Manual warm compressesProcedure or surgery
Lids hygiene of both eyes with wet cotton swabs(OCuSOFT, Inc., Texas, USA).Commercial heated eye patch was use for 10 min. Manual lid massage every 2 weeks, 5 times in total(0，2w, 4w, 4w, 8w).
| Study group | Role | What they receive |
|---|---|---|
| MGD-thermal pulsation group | Experimental | A 12 minutes LIPIFLOW treatment was performed. Receives: Procedure: Thermal pulsation |
| MGD-IPL group | Experimental | IPL was performed every 3 weeks，3 times in total (0, 3w, 6w). Receives: Procedure: Intense pulsed light therapy |
| MGD-manual warm compresses | Experimental | Manual warm compresses were performed every 2 weeks，5 times in total (0, 2w, 4w, 6w, 8w). Receives: Procedure: Manual warm compresses |
| Normal health subject group | No intervention | Normal health subject without intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mophology of meibomian glands
Infrared photography of inversed upper meibomian glands were measured by Meibography pattern of Keratograph 5M (Oculus, Wetzlar, Germany). The infrared images of Meibography were analysed using the new developed software for identifying the mophology features of meibomian glands in millimeter.
Measured: 30 days after commencement of treatment
Functional feature of meibomian glands
Infrared photography of inversed upper and lower meibomian glands were measured by Meibography pattern of Keratograph 5M (Oculus, Wetzlar, Germany). The infrared images of Meibography were analysed using the new developed software for identifying the mean signal intensity of meibomian glands in millimeter.
Measured: 30 days after commencement of treatment
Secondary outcomes (48)
Non-invasive tear-film break-up time
Non-invasived tear-film break-up time is measured by tear film pattern of Keratograph 5M (Oculus, Wetzlar, Germany) with a scale of seconds. Higher values represent a better outcome
Measured: Baseline
Non-invasive tear-film break-up time
Non-invasived tear-film break-up time is measured by tear film pattern of Keratograph 5M (Oculus, Wetzlar, Germany) with a scale of seconds. Higher values represent a better outcome
Measured: 15 days after commencement of treatment
Non-invasive tear-film break-up time
Non-invasived tear-film break-up time is measured by tear film pattern of Keratograph 5M (Oculus, Wetzlar, Germany) with a scale of seconds. Higher values represent a better outcome
Measured: 30 days after commencement of treatment
Non-invasive tear-film break-up time
Non-invasived tear-film break-up time is measured by tear film pattern of Keratograph 5M (Oculus, Wetzlar, Germany) with a scale of seconds. Higher values represent a better outcome
Measured: 90 days after commencement of treatment
Non-invasive tear-film break-up time
Non-invasived tear-film break-up time is measured by tear film pattern of Keratograph 5M (Oculus, Wetzlar, Germany) with a scale of seconds. Higher values represent a better outcome
Measured: 180 days after commencement of treatment
Non-invasive tear meniscus height
Non-invasived tear meniscus height is measured by tear film pattern of Keratograph 5M (Oculus, Wetzlar, Germany) in millimeter. The value higher than 0.20 mm was provided as a normal condition of tear secretion.
Measured: Baseline
Non-invasive tear meniscus height
Non-invasived tear meniscus height is measured by tear film pattern of Keratograph 5M (Oculus, Wetzlar, Germany) in millimeter. The value higher than 0.20 mm was provided as a normal condition of tear secretion.
Measured: 15 days after commencement of treatment
Non-invasive tear meniscus height
Non-invasived tear meniscus height is measured by tear film pattern of Keratograph 5M (Oculus, Wetzlar, Germany) in millimeter. The value higher than 0.20 mm was provided as a normal condition of tear secretion.
Measured: 30 days after commencement of treatment
Non-invasive tear meniscus height
Non-invasived tear meniscus height is measured by tear film pattern of Keratograph 5M (Oculus, Wetzlar, Germany) in millimeter. The value higher than 0.20 mm was provided as a normal condition of tear secretion.
Measured: 90 days after commencement of treatment
Non-invasive tear meniscus height
Non-invasived tear meniscus height is measured by tear film pattern of Keratograph 5M (Oculus, Wetzlar, Germany) in millimeter. The value higher than 0.20 mm was provided as a normal condition of tear secretion.
Measured: 180 days after commencement of treatment
Tear film lipid layer thicknesses
Tear film lipid layer thicknesses were averaged in nanometer(0-100nm) during 20 seconds by LipiView II (Tear Science, Morrisville, NC).
Measured: Baseline
Tear film lipid layer thicknesses
Tear film lipid layer thicknesses were averaged in nanometer(0-100nm) during 20 seconds by LipiView II (Tear Science, Morrisville, NC).
Measured: 15 days after commencement of treatment
Tear film lipid layer thicknesses
Tear film lipid layer thicknesses were averaged in nanometer(0-100nm) during 20 seconds by LipiView II (Tear Science, Morrisville, NC).
Measured: 30 days after commencement of treatment
Tear film lipid layer thicknesses
Tear film lipid layer thicknesses were averaged in nanometer(0-100nm) during 20 seconds by LipiView II (Tear Science, Morrisville, NC).
Measured: 90 days after commencement of treatment
Tear film lipid layer thicknesses
Tear film lipid layer thicknesses were averaged in nanometer(0-100nm) during 20 seconds by LipiView II (Tear Science, Morrisville, NC).
Measured: 180 days after commencement of treatment
The pattern of eye blinks
The pattern of eye blinks including numbers of incompleted and completed blinks during 20 seconds were measured by LipiView II (Tear Science, Morrisville, NC).
Measured: Baseline
The pattern of eye blinks
Tear film lipid layer thicknesses and numbers of incomplete blinks during 20 seconds were measured by LipiView II (Tear Science, Morrisville, NC).
Measured: 15 days after commencement of treatment
The pattern of eye blinks
Tear film lipid layer thicknesses and numbers of incomplete blinks during 20 seconds were measured by LipiView II (Tear Science, Morrisville, NC).
Measured: 30 days after commencement of treatment
The pattern of eye blinks
Tear film lipid layer thicknesses and numbers of incomplete blinks during 20 seconds were measured by LipiView II (Tear Science, Morrisville, NC).
Measured: 90 days after commencement of treatment
The pattern of eye blinks
Tear film lipid layer thicknesses and numbers of incomplete blinks during 20 seconds were measured by LipiView II (Tear Science, Morrisville, NC).
Measured: 180 days after commencement of treatment
Lid margin signs
Three lid margin abnormalities (irregular lid margin, plugging of meibomian gland orifices, and anterior or posterior replacement of the mucocutaneous junction) were scored from 0 through 4 according to the number of these abnormalities that were present in each eye. Higher scores represent a worse outcome.
Measured: baseline
Lid margin signs
Three lid margin abnormalities (irregular lid margin, plugging of meibomian gland orifices, and anterior or posterior replacement of the mucocutaneous junction) were scored from 0 through 4 according to the number of these abnormalities that were present in each eye. Higher scores represent a worse outcome.
Measured: 15 days after commencement of treatment
Lid margin signs
Three lid margin abnormalities (irregular lid margin, plugging of meibomian gland orifices, and anterior or posterior replacement of the mucocutaneous junction) were scored from 0 through 4 according to the number of these abnormalities that were present in each eye. Higher scores represent a worse outcome.
Measured: 30 days after commencement of treatment
Lid margin signs
Three lid margin abnormalities (irregular lid margin, plugging of meibomian gland orifices, and anterior or posterior replacement of the mucocutaneous junction) were scored from 0 through 4 according to the number of these abnormalities that were present in each eye. Higher scores represent a worse outcome.
Measured: 90 days after commencement of treatment
Lid margin signs
Three lid margin abnormalities (irregular lid margin, plugging of meibomian gland orifices, and anterior or posterior replacement of the mucocutaneous junction) were scored from 0 through 4 according to the number of these abnormalities that were present in each eye. Higher scores represent a worse outcome.
Measured: 180 days after commencement of treatment
Meibum expressibility
Meibum expressibility were measured by firm digital pressure of Meibomian gland diagnostic Expressibility (Tear Sience, Morrisville, NC):
For each of these glands, the secretion was graded as follows: 0:no secretion; 1: inspissated/ toothpaste consistency; 2: cloudy liquid secretion and 3: clear liquid secretion19. The scores were then summed in 15 glands to a single meibomian gland yield secretion score (MGYSS) with a range from 0 to 45. Higher values represent a better outcome.
Measured: baseline
Meibum expressibility
Meibum expressibility were measured by firm digital pressure of Meibomian gland diagnostic Expressibility (Tear Sience, Morrisville, NC):
For each of these glands, the secretion was graded as follows: 0:no secretion; 1: inspissated/ toothpaste consistency; 2: cloudy liquid secretion and 3: clear liquid secretion19. The scores were then summed in 15 glands to a single meibomian gland yield secretion score (MGYSS) with a range from 0 to 45. Higher values represent a better outcome.
Measured: 15 days after commencement of treatment
Meibum expressibility
Meibum expressibility were measured by firm digital pressure of Meibomian gland diagnostic Expressibility (Tear Sience, Morrisville, NC):
For each of these glands, the secretion was graded as follows: 0:no secretion; 1: inspissated/ toothpaste consistency; 2: cloudy liquid secretion and 3: clear liquid secretion19. The scores were then summed in 15 glands to a single meibomian gland yield secretion score (MGYSS) with a range from 0 to 45. Higher values represent a better outcome.
Measured: 30 days after commencement of treatment
Meibum expressibility
Meibum expressibility were measured by firm digital pressure of Meibomian gland diagnostic Expressibility (Tear Sience, Morrisville, NC):
For each of these glands, the secretion was graded as follows: 0:no secretion; 1: inspissated/ toothpaste consistency; 2: cloudy liquid secretion and 3: clear liquid secretion19. The scores were then summed in 15 glands to a single meibomian gland yield secretion score (MGYSS) with a range from 0 to 45. Higher values represent a better outcome.
Measured: 90 days after commencement of treatment
Meibum expressibility
Meibum expressibility were measured by firm digital pressure of Meibomian gland diagnostic Expressibility (Tear Sience, Morrisville, NC):
For each of these glands, the secretion was graded as follows: 0:no secretion; 1: inspissated/ toothpaste consistency; 2: cloudy liquid secretion and 3: clear liquid secretion19. The scores were then summed in 15 glands to a single meibomian gland yield secretion score (MGYSS) with a range from 0 to 45. Higher values represent a better outcome.
Measured: 180 days after commencement of treatment
Corneal Fluorescein Staining
Fluorescein was administered into the conjunctival sac under a cobalt blue light from the slit lamp. Corneal epithelial cell disruption was measured via corneal staining (National Eye Institute (NEI) scale (0-3 scale for each area of 5 areas, total score 15). Higher values represent a worse outcome.
Measured: baseline
Corneal Fluorescein Staining
Fluorescein was administered into the conjunctival sac under a cobalt blue light from the slit lamp. Corneal epithelial cell disruption was measured via corneal staining (National Eye Institute (NEI) scale (0-3 scale for each area of 5 areas, total score 15). Higher values represent a worse outcome.
Measured: 15 days after commencement of treatment
Corneal Fluorescein Staining
Fluorescein was administered into the conjunctival sac under a cobalt blue light from the slit lamp. Corneal epithelial cell disruption was measured via corneal staining (National Eye Institute (NEI) scale (0-3 scale for each area of 5 areas, total score 15). Higher values represent a worse outcome.
Measured: 30 days after commencement of treatment
Corneal Fluorescein Staining
Fluorescein was administered into the conjunctival sac under a cobalt blue light from the slit lamp. Corneal epithelial cell disruption was measured via corneal staining (National Eye Institute (NEI) scale (0-3 scale for each area of 5 areas, total score 15). Higher values represent a worse outcome.
Measured: 90 days after commencement of treatment
Corneal Fluorescein Staining
Fluorescein was administered into the conjunctival sac under a cobalt blue light from the slit lamp. Corneal epithelial cell disruption was measured via corneal staining (National Eye Institute (NEI) scale (0-3 scale for each area of 5 areas, total score 15). Higher values represent a worse outcome.
Measured: 180 days after commencement of treatment
Schirmer I test
The tear production was measured with Schirmer strips without anaesthesia 15 minutes after corneal staining.
Measured: baseline
Schirmer I test
The tear production was measured with Schirmer strips without anaesthesia 15 minutes after corneal staining.
Measured: 15 days after commencement of treatment
Schirmer I test
The tear production was measured with Schirmer strips without anaesthesia 15 minutes after corneal staining.
Measured: 30 days after commencement of treatment
Schirmer I test
The tear production was measured with Schirmer strips without anaesthesia 15 minutes after corneal staining.
Measured: 90 days after commencement of treatment
Schirmer I test
The tear production was measured with Schirmer strips without anaesthesia 15 minutes after corneal staining.
Measured: 180 days after commencement of treatment
Mophology of meibomian glands
Infrared photography of inversed upper meibomian glands were measured by Meibography pattern of Keratograph 5M (Oculus, Wetzlar, Germany). The infrared images of Meibography were analysed using the new developed software for identifying the mophology features of meibomian glands in millimeter.
Measured: 15 days after commencement of treatment
Mophology of meibomian glands
Infrared photography of inversed upper meibomian glands were measured by Meibography pattern of Keratograph 5M (Oculus, Wetzlar, Germany). The infrared images of Meibography were analysed using the new developed software for identifying the mophology features of meibomian glands in millimeter.
Measured: 90 days after commencement of treatment
Mophology of meibomian glands
Infrared photography of inversed upper meibomian glands were measured by Meibography pattern of Keratograph 5M (Oculus, Wetzlar, Germany). The infrared images of Meibography were analysed using the new developed software for identifying the mophology features of meibomian glands in millimeter.
Measured: 180 days after commencement of treatment
Mophology of meibomian glands
Infrared photography of inversed upper meibomian glands were measured by Meibography pattern of Keratograph 5M (Oculus, Wetzlar, Germany). The infrared images of Meibography were analysed using the new developed software for identifying the mophology features of meibomian glands in millimeter.
Measured: Baseline
Functional feature of meibomian glands
Infrared photography of inversed upper and lower meibomian glands were measured by Meibography pattern of Keratograph 5M (Oculus, Wetzlar, Germany). The infrared images of Meibography were analysed using the new developed software for identifying the mean signal intensity of meibomian glands in millimeter.
Measured: Baseline
Functional feature of meibomian glands
Infrared photography of inversed upper and lower meibomian glands were measured by Meibography pattern of Keratograph 5M (Oculus, Wetzlar, Germany). The infrared images of Meibography were analysed using the new developed software for identifying the mean signal intensity of meibomian glands in millimeter.
Measured: 15 days after commencement of treatment
Functional feature of meibomian glands
Infrared photography of inversed upper and lower meibomian glands were measured by Meibography pattern of Keratograph 5M (Oculus, Wetzlar, Germany). The infrared images of Meibography were analysed using the new developed software for identifying the mean signal intensity of meibomian glands in millimeter.
Measured: 90 days after commencement of treatment
Functional feature of meibomian glands
Infrared photography of inversed upper and lower meibomian glands were measured by Meibography pattern of Keratograph 5M (Oculus, Wetzlar, Germany). The infrared images of Meibography were analysed using the new developed software for identifying the mean signal intensity of meibomian glands in millimeter.
Measured: 180 days after commencement of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start12 Oct 2020
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Meibomian Gland DysfunctionStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The recruitment of subjects must meet the diagnosis criteria of MGD the international workshop on meibomian gland dysfunction.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Yuan, Zhongshan Ophthalmic Center, Sun Yat-sen University
- Investigators
- Jin Yuan, PHD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052841
- Sponsor's protocol ID
- 20190722
- Status last verified
- Apr 2023
- First submitted
- 30 Jul 2019
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol
Publications
Arita R, Suehiro J, Haraguchi T, Shirakawa R, Tokoro H, Amano S. Objective image analysis of the meibomian gland area. Br J Ophthalmol. 2014 Jun;98(6):746-55. doi: 10.1136/bjophthalmol-2012-303014. Epub 2013 Jun 27.
PubMed 23813417Nelson JD, Shimazaki J, Benitez-del-Castillo JM, Craig JP, McCulley JP, Den S, Foulks GN. The international workshop on meibomian gland dysfunction: report of the definition and classification subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1930-7. doi: 10.1167/iovs.10-6997b. Print 2011 Mar. No abstract available.
PubMed 21450914Schein OD, Munoz B, Tielsch JM, Bandeen-Roche K, West S. Prevalence of dry eye among the elderly. Am J Ophthalmol. 1997 Dec;124(6):723-8. doi: 10.1016/s0002-9394(14)71688-5.
PubMed 9402817Lekhanont K, Rojanaporn D, Chuck RS, Vongthongsri A. Prevalence of dry eye in Bangkok, Thailand. Cornea. 2006 Dec;25(10):1162-7. doi: 10.1097/01.ico.0000244875.92879.1a.
PubMed 17172891Uchino M, Dogru M, Yagi Y, Goto E, Tomita M, Kon T, Saiki M, Matsumoto Y, Uchino Y, Yokoi N, Kinoshita S, Tsubota K. The features of dry eye disease in a Japanese elderly population. Optom Vis Sci. 2006 Nov;83(11):797-802. doi: 10.1097/01.opx.0000232814.39651.fa.
PubMed 17106406Chia EM, Mitchell P, Rochtchina E, Lee AJ, Maroun R, Wang JJ. Prevalence and associations of dry eye syndrome in an older population: the Blue Mountains Eye Study. Clin Exp Ophthalmol. 2003 Jun;31(3):229-32. doi: 10.1046/j.1442-9071.2003.00634.x.
PubMed 12786773Schaumberg DA, Sullivan DA, Buring JE, Dana MR. Prevalence of dry eye syndrome among US women. Am J Ophthalmol. 2003 Aug;136(2):318-26. doi: 10.1016/s0002-9394(03)00218-6.
PubMed 12888056Wise RJ, Sobel RK, Allen RC. Meibography: A review of techniques and technologies. Saudi J Ophthalmol. 2012 Oct;26(4):349-56. doi: 10.1016/j.sjopt.2012.08.007.
PubMed 23961019Tomlinson A, Bron AJ, Korb DR, Amano S, Paugh JR, Pearce EI, Yee R, Yokoi N, Arita R, Dogru M. The international workshop on meibomian gland dysfunction: report of the diagnosis subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2006-49. doi: 10.1167/iovs.10-6997f. Print 2011 Mar. No abstract available.
PubMed 21450918Simcock B. The role of the intrauterine device in contraceptive practice. Aust Fam Physician. 1976 Mar;5(2):124-39.
PubMed 942338Knop E, Knop N, Brewitt H, Pleyer U, Rieck P, Seitz B, Schirra F. [Meibomian glands : part III. Dysfunction - argument for a discrete disease entity and as an important cause of dry eye]. Ophthalmologe. 2009 Nov;106(11):966-79. doi: 10.1007/s00347-009-2043-9. German.
PubMed 19941140Arita R, Itoh K, Maeda S, Maeda K, Furuta A, Fukuoka S, Tomidokoro A, Amano S. Proposed diagnostic criteria for obstructive meibomian gland dysfunction. Ophthalmology. 2009 Nov;116(11):2058-63.e1. doi: 10.1016/j.ophtha.2009.04.037. Epub 2009 Sep 10.
PubMed 19744718Koh YW, Celik T, Lee HK, Petznick A, Tong L. Detection of meibomian glands and classification of meibography images. J Biomed Opt. 2012 Aug;17(8):086008. doi: 10.1117/1.JBO.17.8.086008.
PubMed 23224195Knop E, Knop N, Millar T, Obata H, Sullivan DA. The international workshop on meibomian gland dysfunction: report of the subcommittee on anatomy, physiology, and pathophysiology of the meibomian gland. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1938-78. doi: 10.1167/iovs.10-6997c. Print 2011 Mar. No abstract available.
PubMed 21450915
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Morphological Analysis of Meibomian Glands
- ClinicalTrials.gov ID
- NCT04052841
- Acronym / sponsor ID
- 20190722
- Conditions
- Meibomian Gland Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 12 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An automated quantitative meibomian gland analyzer based on all kinds of infrared meibomian gland images was develop to obtain more detail in meibomian gland, including width, length, area, signal intensity correlated to the quality of meibum, deformation index and ratio of area of each visible specific gland. The purpose of this study is present as separate sections the following points: (1) to compared the detailed characteristics of meibomian glands in normal subjects, Meibomian gland dysfunction (MGD) patients by the automated quantitative analyzer; (2) to identify the inter-examiner and intra-examiner repeatability of the new technique; (3) to explore the correlation among morphological and functional parameters of meibomian gland and risk factors，clinical symptoms and signs; (4) to explore the sensitivity and specificity of meibomian gland morphological and functional parameters in MGD diagnosis. (5) using morphological and functional parameters as new assessment of MGD severity and efficacy indicators for treatment.
Detailed description
Meibomian glands are essential for maintaining ocular surface health and integrity secrete various lipid components to forms a lipid layer to prevent excessive tear evaporation. Functional disorders of the meibomian glands, referred to today as meibomian gland dysfunction (MGD), are increasingly recognized as a high incidence disease commonly characterized by terminal duct obstruction and/or abnormal glandular secretion, often results in ocular surface epithelium damage, chronic blepharitis and dry eye disease that significantly reduces quality of life. A wide variation of the prevalence of MGD were reported from 0.39% to 69.3%, which is likely due to lack of diagnostic methods. To identify which clinical features are likely to be predictive of progressive disease in MGD may indicate the early diagnosis and proper treatment strategies.
Histologic section through the normal meibomian glands and the obstructed human meibomian gland revealed that obstruction of orifice in MGD could lead to dilation of the central duct, damage of the secretory meibocytes and finally result in atrophy of dilated meibomian glands and glands drop-out. It was thus be accepted that detailed changes of meibomian glands morphology are key signs to diagnose and evaluate the severity of MGD. The detailed changes including dilation, distortion, shortening and loss of visualisation of glands which can be directly observed and visual assessment by the developed of non-contact meibomian gland infrared imaging technology. Quantitative evaluations of meibomian glands were obtain by developing imaging processing techniques. The most common use is the image editing software Image J (National Institute of Health; http://imagej.nih.gov/ij) which can identify the gland region on the image manually by the users and may lead to inter-observer variability. Koh et al., first applied original algorithms to automatically analysed gland loss in meibography images with a manually pre-processing. Reiko et al., then develop an objective and automatic system to measure the meibomian gland area. However, the existing methods of meibomian gland analysis have been limited to clinical use where large number of images needs to be analyzed efficiently due to the inter-observer variability or time-consuming process.
Meanwhile, the existing quantitative morphological parameters obtain by those imaging processing techniques, including percentage of MG drop-out and gland atrophy area, were suggested to not only be advanced stages or terminal changes in MGD, but also occurs as an age-related atrophic process. The early findings of MGD induced by the primary pathologic obstruction including degenerative gland dilation, irregularly shapes of gland and change of meibum quality are still difficult to be evaluated automatically and quantitively from the image. Moreover, the meibomian gland drop-out is still an approximate assessment without specific pattern. Whether the atrophy or loss occur in upper or lower eyelids, central, distal or proximal, total loss of gland or partial loss of gland has the greatest effect on the pathology progress of MGD will be important to identify. Thus, a comprehensive analysis technique to automatically detect multi-information of meibomian gland morphology will benefit the future early diagnosis and management of MGD.
Recently, an automated quantitative meibomian gland analyzer based on all kinds of infrared meibomian gland images was develop to obtain more detail in meibomian gland, including width, length, area, signal intensity correlated to the quality of meibum, deformation index and ratio of area of each visible specific gland. The purpose of this study is present as separate sections the following points: (1) to compared the detailed characteristics of meibomian glands in normal subjects and MGD patients by the automated quantitative analyzer; (2) to identify the inter-examiner and intra-examiner repeatability of the new technique; (3) to explore the correlation among morphological and functional parameters of meibomian gland and risk factors，clinical symptoms and signs; (4) to explore the sensitivity and specificity of meibomian gland morphological and functional parameters in MGD diagnosis. (5) using morphological and functional parameters as new assessment of MGD severity and efficacy indicators for treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The recruitment of subjects must meet the diagnosis criteria of MGD the international workshop on meibomian gland dysfunction.
| Arm | Type | Receives |
|---|---|---|
| MGD-thermal pulsation group | Experimental | Procedure: Thermal pulsationA 12 minutes LIPIFLOW treatment was performed. |
| MGD-IPL group | Experimental | Procedure: Intense pulsed light therapyIPL was performed every 3 weeks，3 times in total (0, 3w, 6w). |
| MGD-manual warm compresses | Experimental | Procedure: Manual warm compressesManual warm compresses were performed every 2 weeks，5 times in total (0, 2w, 4w, 6w, 8w). |
| Normal health subject group | No intervention | –Normal health subject without intervention. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Clinical diagnosis of MGD: The diagnosis of MGD was based on an altered quality of expressed secretions and/or decreased or absent expression.
- Patients without ≥2/3 Meibomian glands atrophy.
- Fitzpatrick skin type 1-4.
- Negative history or condition of ocular or systemic illness based on evaluation by a research physician.
- Patients and healthy volunteers with ocular allergies, trauma, contact lens wear, continuous medications usage such as tretinoin, isotretinoin, antidepressant medications, photosensitive drugs, glucocorticoids and immunomodulators, or have used them within one month.
Key exclusion criteria (4 listed)
- Patients have abnormalities of ocular surface function or eyelid function, or presence of precancerous lesions, cancer or pigmentation in the eyelid area.
- Patients who have plans to receive ocular surgeries (e.g., cataract, myopic refractive surgery) within 6 months.
- Patients who have been treated with lacrimal punctum embolization within one month.
- Patients with disease that could lead to ADDE, such as Sjogren syndrome and a lacrimal gland abnormality.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal pulsationParticipants underwent a single LipiFlow® thermal pulsation system (TearScience Inc., Morrisville, NC,USA) treatment on the first visit: after lid hygiene with wet cotton swabs(OCuSOFT, Inc., Texas, USA) and instillation of anesthetic eye drops (Alcaine, proparacaine hydrochloride 0.4 ml/2mg) in both eyes, sterile eye cups were placed on to the conjunctival sac as instructed by the manufacturer, after 12 minutes of upper and lower palpebral conjunctival surfaces heat while simultaneously graded pulsatile pressure applying, eye cups were removed slightly. | Procedure or surgery | MGD-thermal pulsation group |
| Intense pulsed light therapyLid hygiene with wet cotton swabs(OCuSOFT, Inc., Texas, USA) before treatment. Intense pulsed light (IPL) with a range of wavelength (570 or 620 nm) was performed every 3 weeks，3 times in total (0, 3w, 6w). 10 pulses were transmited from one tragus through nose to the other tragus was a single pass, each treatment needed to do 2 passes. Manual lid massage was done after per IPL treatment. | Procedure or surgery | MGD-IPL group |
| Manual warm compressesLids hygiene of both eyes with wet cotton swabs(OCuSOFT, Inc., Texas, USA).Commercial heated eye patch was use for 10 min. Manual lid massage every 2 weeks, 5 times in total(0，2w, 4w, 4w, 8w). | Procedure or surgery | MGD-manual warm compresses |
Primary outcome
Mophology of meibomian glands
Time frame: 30 days after commencement of treatment
Infrared photography of inversed upper meibomian glands were measured by Meibography pattern of Keratograph 5M (Oculus, Wetzlar, Germany). The infrared images of Meibography were analysed using the new developed software for identifying the mophology features of meibomian glands in millimeter.
Functional feature of meibomian glands
Time frame: 30 days after commencement of treatment
Infrared photography of inversed upper and lower meibomian glands were measured by Meibography pattern of Keratograph 5M (Oculus, Wetzlar, Germany). The infrared images of Meibography were analysed using the new developed software for identifying the mean signal intensity of meibomian glands in millimeter.
48 secondary outcomes
Non-invasive tear-film break-up time
Time frame: Baseline
Non-invasive tear-film break-up time
Time frame: 15 days after commencement of treatment
Non-invasive tear-film break-up time
Time frame: 30 days after commencement of treatment
Non-invasive tear-film break-up time
Time frame: 90 days after commencement of treatment
Non-invasive tear-film break-up time
Time frame: 180 days after commencement of treatment
Non-invasive tear meniscus height
Time frame: Baseline
Non-invasive tear meniscus height
Time frame: 15 days after commencement of treatment
Non-invasive tear meniscus height
Time frame: 30 days after commencement of treatment
Non-invasive tear meniscus height
Time frame: 90 days after commencement of treatment
Non-invasive tear meniscus height
Time frame: 180 days after commencement of treatment
Tear film lipid layer thicknesses
Time frame: Baseline
Tear film lipid layer thicknesses
Time frame: 15 days after commencement of treatment
Tear film lipid layer thicknesses
Time frame: 30 days after commencement of treatment
Tear film lipid layer thicknesses
Time frame: 90 days after commencement of treatment
Tear film lipid layer thicknesses
Time frame: 180 days after commencement of treatment
The pattern of eye blinks
Time frame: Baseline
The pattern of eye blinks
Time frame: 15 days after commencement of treatment
The pattern of eye blinks
Time frame: 30 days after commencement of treatment
The pattern of eye blinks
Time frame: 90 days after commencement of treatment
The pattern of eye blinks
Time frame: 180 days after commencement of treatment
Lid margin signs
Time frame: baseline
Lid margin signs
Time frame: 15 days after commencement of treatment
Lid margin signs
Time frame: 30 days after commencement of treatment
Lid margin signs
Time frame: 90 days after commencement of treatment
Lid margin signs
Time frame: 180 days after commencement of treatment
Meibum expressibility
Time frame: baseline
Meibum expressibility
Time frame: 15 days after commencement of treatment
Meibum expressibility
Time frame: 30 days after commencement of treatment
Meibum expressibility
Time frame: 90 days after commencement of treatment
Meibum expressibility
Time frame: 180 days after commencement of treatment
Corneal Fluorescein Staining
Time frame: baseline
Corneal Fluorescein Staining
Time frame: 15 days after commencement of treatment
Corneal Fluorescein Staining
Time frame: 30 days after commencement of treatment
Corneal Fluorescein Staining
Time frame: 90 days after commencement of treatment
Corneal Fluorescein Staining
Time frame: 180 days after commencement of treatment
Schirmer I test
Time frame: baseline
Schirmer I test
Time frame: 15 days after commencement of treatment
Schirmer I test
Time frame: 30 days after commencement of treatment
Schirmer I test
Time frame: 90 days after commencement of treatment
Schirmer I test
Time frame: 180 days after commencement of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Results publication: PubMed 23813417Arita R, Suehiro J, Haraguchi T, Shirakawa R, Tokoro H, Amano S. Objective image analysis of the meibomian gland area. Br J Ophthalmol. 2014 Jun;98(6):746-55. doi: 10.1136/bjophthalmol-2012-303014. Epub 2013 Jun 27.
- Results publication: PubMed 21450914Nelson JD, Shimazaki J, Benitez-del-Castillo JM, Craig JP, McCulley JP, Den S, Foulks GN. The international workshop on meibomian gland dysfunction: report of the definition and classification subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1930-7. doi: 10.1167/iovs.10-6997b. Print 2011 Mar. No abstract available.
- Results publication: PubMed 9402817Schein OD, Munoz B, Tielsch JM, Bandeen-Roche K, West S. Prevalence of dry eye among the elderly. Am J Ophthalmol. 1997 Dec;124(6):723-8. doi: 10.1016/s0002-9394(14)71688-5.
- Results publication: PubMed 17172891Lekhanont K, Rojanaporn D, Chuck RS, Vongthongsri A. Prevalence of dry eye in Bangkok, Thailand. Cornea. 2006 Dec;25(10):1162-7. doi: 10.1097/01.ico.0000244875.92879.1a.
- Results publication: PubMed 17106406Uchino M, Dogru M, Yagi Y, Goto E, Tomita M, Kon T, Saiki M, Matsumoto Y, Uchino Y, Yokoi N, Kinoshita S, Tsubota K. The features of dry eye disease in a Japanese elderly population. Optom Vis Sci. 2006 Nov;83(11):797-802. doi: 10.1097/01.opx.0000232814.39651.fa.
- Results publication: PubMed 12786773Chia EM, Mitchell P, Rochtchina E, Lee AJ, Maroun R, Wang JJ. Prevalence and associations of dry eye syndrome in an older population: the Blue Mountains Eye Study. Clin Exp Ophthalmol. 2003 Jun;31(3):229-32. doi: 10.1046/j.1442-9071.2003.00634.x.
- Results publication: PubMed 12888056Schaumberg DA, Sullivan DA, Buring JE, Dana MR. Prevalence of dry eye syndrome among US women. Am J Ophthalmol. 2003 Aug;136(2):318-26. doi: 10.1016/s0002-9394(03)00218-6.
- Results publication: PubMed 23961019Wise RJ, Sobel RK, Allen RC. Meibography: A review of techniques and technologies. Saudi J Ophthalmol. 2012 Oct;26(4):349-56. doi: 10.1016/j.sjopt.2012.08.007.
- Results publication: PubMed 21450918Tomlinson A, Bron AJ, Korb DR, Amano S, Paugh JR, Pearce EI, Yee R, Yokoi N, Arita R, Dogru M. The international workshop on meibomian gland dysfunction: report of the diagnosis subcommittee. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):2006-49. doi: 10.1167/iovs.10-6997f. Print 2011 Mar. No abstract available.
- Results publication: PubMed 942338Simcock B. The role of the intrauterine device in contraceptive practice. Aust Fam Physician. 1976 Mar;5(2):124-39.
- Results publication: PubMed 19941140Knop E, Knop N, Brewitt H, Pleyer U, Rieck P, Seitz B, Schirra F. [Meibomian glands : part III. Dysfunction - argument for a discrete disease entity and as an important cause of dry eye]. Ophthalmologe. 2009 Nov;106(11):966-79. doi: 10.1007/s00347-009-2043-9. German.
- Results publication: PubMed 19744718Arita R, Itoh K, Maeda S, Maeda K, Furuta A, Fukuoka S, Tomidokoro A, Amano S. Proposed diagnostic criteria for obstructive meibomian gland dysfunction. Ophthalmology. 2009 Nov;116(11):2058-63.e1. doi: 10.1016/j.ophtha.2009.04.037. Epub 2009 Sep 10.
- Individual participant dataSharing planned: Yes. Study protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Yuan, PHD principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermal pulsation, Intense pulsed light therapy and Manual warm compresses in people with Meibomian Gland Dysfunction, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuqing Deng, MD (18120557291, 15927646647@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mophology of meibomian glands (time frame: 30 days after commencement of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04052841, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.