Dry Eye DiseaseNCT06023108
Assess the Effects of Spectacles or Orthokeratology on Dry Eye Parameters in Children and Adolescents.
A study testing Orthokeratology and Spectacles in people with Dry Eye Disease, run by He Eye Hospital at 1 site in China.
Trial summary
Orthokeratology(OK) is currently one of the effective methods for treating myopia, reshaping the corneal epithelium to change refractive power. Due to its contact with the ocular surface, long-term wearing could lead to symptoms and signs of dry eye disease(DED) , as well as changes in tear film stability. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- Orthokeratology and Spectacles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2023to 30 Jan 2024
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- (i)myopia up to -5.5D; and with-the-rule astigmatism of up to 1.5 DC or against-the rule astigmatism of <-0.5DC with keratometry from 40 to 45D ; (ii)participants and guardians agree to be randomly assigned and are willing to cooperate with doctors for follow-up and examination.
Who cannot join
- existing ocular trauma, infectious diseases, recent surgical history; (ii) keratitis or any ocular inflammation or infection; recently wearing contact lenses; allergy history; (iii) glaucoma, active uveitis or retinal disease; (iv) systemic diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
He Eye Hospital
Shenyang, Liaoning, 110001
Yilin Song, MD, 0086-18842649801, songyilin1432@163.com
Emmanuel Eric Pazo, PHD, 0086-18612782131, ericpazo@outlook.com
About this study
Official title: A Single Center,Randomized,Controlled Trial Assessing the Effects of Spectacles or Orthokeratology on Dry Eye Parameters in Children and Adolescents.
Orthokeratology(OK) is currently one of the effective methods for treating myopia, reshaping the corneal epithelium to change refractive power. Due to its contact with the ocular surface, long-term wearing could lead to symptoms and signs of dry eye disease(DED) , as well as changes in tear film stability. This prospective study randomly divided 300 children and adolescents with myopia into OK group and spectacles group, with a follow-up of 12 months. At baseline, 1, 3, 6, and 12 months, non-invasive tear breakup time (NIBUT), ocular surface disease index (OSDI) and visual analogue score (VAS) score, tear meniscus height (TMH), conjunctival hyperemia (RS score) and meibomian gland (MG) scores, tear MMP-9 concentration, and point-of-care Lymphotoxin alpha (LTA) test.
Read the detailed description
This study will be conducted in compliance with the tenets of the Declaration of Helsinki and the Institutional Review Board of He Eye Specialist Hospital, Shenyang, China [ethics approval number:
In recent years, the prevalence of myopia has significantly increased nationwide, The incidence rate of myopia among adolescents in China has risen significantly, causing blurred vision. Severe myopia can cause complications that threaten vision, such as glaucoma and macula disease. It would be highly undesirable to increase the social burden. Myopia can be corrected by orthokeratology (OK) and spectacles. It has been shown in numerous researches that orthokeratology lens are recognized as one of the effective methods in the treatment of myopia, has been widely used nationwide. In current years, the clinical treatment of myopia by OK lens in adolescents are increasingly confirmed to prevent the progression. Traditional OK lenses change refractive power by reshaping the corneal Epithelium (leading to the redistribution of corneal epithelium). As the overnight OK lens directly contact the ocular surface, the patients may endure symptoms and signs of dry eye disease (DED), which may even have some impact on the health of the ocular surface, including potential complications such as Keratitis. In addition, corneal staining often has occurred in ook wearers. According to previous studies, it has shown that wearing contact lens will affect the tear film stability, damage the function of the meibomian gland, tear film thinning, its affect ocular inflammation. Recent studies have also shown that OK continuous wearing has the least impact at 12 months. In order to ensure the safety of long-term wearing ok lenses in children and adolescents, the effect of OK lens on tear film and meibomian gland demonstrated further exploration.
The aim of this study is to evaluate the effect of OK on the ocular surface and meibomian gland function in children and adolescents. To assess the effect of OK on ocular surface and meibomian gland function in children and adolescents, so as to improve the application of the clinical.
- Conditions
- Dry Eye Disease
- Being tested
- Orthokeratology, Spectacles
- Keywords
- Myopia, Orthokeratology, Tear film, Dry eye
- Medical subject headings
- Dry Eye Syndromes, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrthokeratologyDevice
Also called OK lenses
OK lenses will be used to evaluate the condition that causes dry eye in the treatment of myopia.
SpectaclesDevice
Spectacles will be used to evaluate the condition that causes dry eye in the treatment of myopia.
| Study group | Role | What they receive |
|---|---|---|
| Orthokeratology group | Experimental | Participants in OK lenses group will wear OK lenses at least 8 hours per day for 12 months. Receives: Device: Orthokeratology |
| Spectacles group | Active comparator | Participants in spectacles group will wear per day for 12 months. Receives: Device: Spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-invasive tear break-up time
Non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded.
Measured: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
OSDI Score
Chinese translated, and validated OSDI (Allergan Inc, Irvine, USA) version will be used to assess and quantify DE symptom. The 12 items of the questionnaire can be tabulated into a score that ranges from 0 (no symptoms) to 100 (severe symptoms) points.
Measured: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
VAS score
VAS is used to evaluate subjective symptoms, such as patient symptoms, emotions, etc. Composed of a 100 mm straight line, the end is defined as the limit of pain to be measured, resulting in a 100 component scale. The patient rated their eye discomfort by marking the continuity from 'no eye discomfort' (score 0) to 'my eye discomfort is as bad as ever' (score 100).
Measured: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
Secondary outcomes (5)
Tear meniscus height (TMH)
Tear meniscus height using the Keratograph 5M (Oculus, Germany) topographer
Measured: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
Conjunctival hyperemia (RS score)
Conjunctival hyperemia (RS score) will be assessed by keratograph image (Oculus, Germany) of 1156*873 pixels, redness score (RS) (accurate to 0.1 U) was displayed on the computer screen that ranged from 0.0 to 4.0.
Measured: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
Meibomian gland score (meiboscore)
Meibomian gland score will be assessed by keratograph image (Oculus, Germany) .The meibomian gland can be scored that ranges from grade 0 (no loss) to grade 3 (more than two third loss).
Measured: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
MMP-9 detection
Inflammation Dry, (Rapid Pathogen Screening Inc., Sarasota, FL, USA) is a patented and proprietary modification of a traditional lateral flow device and uses direct sampling microfiltration technology.
Measured: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
LTA
LTA will be measured using an immunochromatography assay by collecting 1ul tear samples from the lateral canthus using a capillary tear collector. To assess the concentration of LTA in the tear samples, a commercial reagent card (S05B, Seinda Biomedical Corporation, Guangdong, China) based on colloidal gold and immunochromatographic analysis was utilized.
Measured: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start23 Nov 2023 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- He Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel Eric E Pazo, PHD, Study chair, He Eye Hospital, Shenyang, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023108
- Sponsor's protocol ID
- orthokeratology 2023
- Status last verified
- Sep 2023
- First submitted
- 29 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study's findings will be shared regardless of the effect's direction. All possible beneficiaries of the research, including patients, carers, family, doctors, advisory boards, and medical boards, will receive trial data. Publications in high-impact, open-access medical journals and talks at national and international medical conferences will serve this purpose.
Publications
Tao Z, Wang J, Zhu M, Lin Z, Zhao J, Tang Y, Deng H. Does Orthokeratology Wearing Affect the Tear Quality of Children? Front Pediatr. 2022 Jan 18;9:773484. doi: 10.3389/fped.2021.773484. eCollection 2021.
PubMed 35118029Hui W, Xiao-Feng H, Song-Guo L, Jing-Jing W, Xuan H, Yong T. Application of orthokeratology on myopia control and its effect on ocular surface and meibomian gland function in Chinese myopic adolescents. Front Med (Lausanne). 2022 Dec 8;9:979334. doi: 10.3389/fmed.2022.979334. eCollection 2022.
PubMed 36569150Yan ZP. Dry eye symptoms and signs in children wearing OK lenses for six months in China. J Fr Ophtalmol. 2020 Mar;43(3):211-215. doi: 10.1016/j.jfo.2019.07.029. Epub 2020 Jan 27.
PubMed 32000988Fricke TR, Holden BA, Wilson DA, Schlenther G, Naidoo KS, Resnikoff S, Frick KD. Global cost of correcting vision impairment from uncorrected refractive error. Bull World Health Organ. 2012 Oct 1;90(10):728-38. doi: 10.2471/BLT.12.104034. Epub 2012 Jul 12.
PubMed 23109740Kakita T, Hiraoka T, Oshika T. Influence of overnight orthokeratology on axial elongation in childhood myopia. Invest Ophthalmol Vis Sci. 2011 Apr 6;52(5):2170-4. doi: 10.1167/iovs.10-5485.
PubMed 21212181He M, Du Y, Liu Q, Ren C, Liu J, Wang Q, Li L, Yu J. Effects of orthokeratology on the progression of low to moderate myopia in Chinese children. BMC Ophthalmol. 2016 Jul 27;16:126. doi: 10.1186/s12886-016-0302-5.
PubMed 27464993Nti AN, Berntsen DA. Optical changes and visual performance with orthokeratology. Clin Exp Optom. 2020 Jan;103(1):44-54. doi: 10.1111/cxo.12947. Epub 2019 Aug 4.
PubMed 31378996Wang X, Li J, Zhang R, Li N, Pang Y, Zhang Y, Wei R. The Influence of Overnight Orthokeratology on Ocular Surface and Meibomian Gland Dysfunction in Teenagers with Myopia. J Ophthalmol. 2019 Jan 21;2019:5142628. doi: 10.1155/2019/5142628. eCollection 2019.
PubMed 30805209Yang L, Zhang L, Jian Hu R, Yu PP, Jin X. The influence of overnight orthokeratology on ocular surface and dry eye-related cytokines IL-17A, IL-6, and PGE2 in children. Cont Lens Anterior Eye. 2021 Feb;44(1):81-88. doi: 10.1016/j.clae.2020.04.001. Epub 2020 Apr 30.
PubMed 32359968Yu H, Yuan Y, Wu W, Zeng W, Tong L, Zhang Y, Feng Y. Orthokeratology Lens Wear for 2 Years in Children Did Not Alter Tear Film Lipid Thickness by Non-Invasive Interferometry. Front Med (Lausanne). 2022 Feb 10;9:821106. doi: 10.3389/fmed.2022.821106. eCollection 2022.
PubMed 35223920Lee J, Hwang G, Ha M, Kim HS, Han K, Na KS. Evaluation of the meibomian glands using the tear interferometer wearing orthokeratology lenses. BMC Ophthalmol. 2022 Mar 24;22(1):133. doi: 10.1186/s12886-022-02365-3.
PubMed 35331178Song Y, Chen J, Qin G, Xu L, He W, Yu S, Pazo EE, He X. A protocol for a single center, randomized, controlled trial assessing the effects of spectacles or orthokeratology on dry eye parameters in children and adolescents. Heliyon. 2024 Sep 12;10(18):e37779. doi: 10.1016/j.heliyon.2024.e37779. eCollection 2024 Sep 30.
PubMed 39323780
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center,Randomized,Controlled Trial Assessing the Effects of Spectacles or Orthokeratology on Dry Eye Parameters in Children and Adolescents.
- ClinicalTrials.gov ID
- NCT06023108
- Acronym / sponsor ID
- orthokeratology 2023
- Conditions
- Dry Eye Disease
- Keywords
- Myopia, Orthokeratology, Tear film, Dry eye
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- He Eye HospitalUniversity, hospital or other
- Study start
- 23 Nov 2023 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 5 Sep 2023 (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.
Orthokeratology(OK) is currently one of the effective methods for treating myopia, reshaping the corneal epithelium to change refractive power. Due to its contact with the ocular surface, long-term wearing could lead to symptoms and signs of dry eye disease(DED) , as well as changes in tear film stability. This prospective study randomly divided 300 children and adolescents with myopia into OK group and spectacles group, with a follow-up of 12 months. At baseline, 1, 3, 6, and 12 months, non-invasive tear breakup time (NIBUT), ocular surface disease index (OSDI) and visual analogue score (VAS) score, tear meniscus height (TMH), conjunctival hyperemia (RS score) and meibomian gland (MG) scores, tear MMP-9 concentration, and point-of-care Lymphotoxin alpha (LTA) test.
Detailed description
This study will be conducted in compliance with the tenets of the Declaration of Helsinki and the Institutional Review Board of He Eye Specialist Hospital, Shenyang, China [ethics approval number:
In recent years, the prevalence of myopia has significantly increased nationwide, The incidence rate of myopia among adolescents in China has risen significantly, causing blurred vision. Severe myopia can cause complications that threaten vision, such as glaucoma and macula disease. It would be highly undesirable to increase the social burden. Myopia can be corrected by orthokeratology (OK) and spectacles. It has been shown in numerous researches that orthokeratology lens are recognized as one of the effective methods in the treatment of myopia, has been widely used nationwide. In current years, the clinical treatment of myopia by OK lens in adolescents are increasingly confirmed to prevent the progression. Traditional OK lenses change refractive power by reshaping the corneal Epithelium (leading to the redistribution of corneal epithelium). As the overnight OK lens directly contact the ocular surface, the patients may endure symptoms and signs of dry eye disease (DED), which may even have some impact on the health of the ocular surface, including potential complications such as Keratitis. In addition, corneal staining often has occurred in ook wearers. According to previous studies, it has shown that wearing contact lens will affect the tear film stability, damage the function of the meibomian gland, tear film thinning, its affect ocular inflammation. Recent studies have also shown that OK continuous wearing has the least impact at 12 months. In order to ensure the safety of long-term wearing ok lenses in children and adolescents, the effect of OK lens on tear film and meibomian gland demonstrated further exploration.
The aim of this study is to evaluate the effect of OK on the ocular surface and meibomian gland function in children and adolescents. To assess the effect of OK on ocular surface and meibomian gland function in children and adolescents, so as to improve the application of the clinical.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthokeratology group | Experimental | Device: OrthokeratologyParticipants in OK lenses group will wear OK lenses at least 8 hours per day for 12 months. |
| Spectacles group | Active comparator | Device: SpectaclesParticipants in spectacles group will wear per day for 12 months. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- (i)myopia up to -5.5D; and with-the-rule astigmatism of up to 1.5 DC or against-the rule astigmatism of <-0.5DC with keratometry from 40 to 45D ; (ii)participants and guardians agree to be randomly assigned and are willing to cooperate with doctors for follow-up and examination.
Key exclusion criteria (1 listed)
- existing ocular trauma, infectious diseases, recent surgical history; (ii) keratitis or any ocular inflammation or infection; recently wearing contact lenses; allergy history; (iii) glaucoma, active uveitis or retinal disease; (iv) systemic diseases.
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 |
|---|---|---|
| OrthokeratologyAlso: OK lensesOK lenses will be used to evaluate the condition that causes dry eye in the treatment of myopia. | Device | Orthokeratology group |
| SpectaclesSpectacles will be used to evaluate the condition that causes dry eye in the treatment of myopia. | Device | Spectacles group |
Primary outcome
Non-invasive tear break-up time
Time frame: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
Non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded.
OSDI Score
Time frame: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
Chinese translated, and validated OSDI (Allergan Inc, Irvine, USA) version will be used to assess and quantify DE symptom. The 12 items of the questionnaire can be tabulated into a score that ranges from 0 (no symptoms) to 100 (severe symptoms) points.
VAS score
Time frame: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
VAS is used to evaluate subjective symptoms, such as patient symptoms, emotions, etc. Composed of a 100 mm straight line, the end is defined as the limit of pain to be measured, resulting in a 100 component scale. The patient rated their eye discomfort by marking the continuity from 'no eye discomfort' (score 0) to 'my eye discomfort is as bad as ever' (score 100).
5 secondary outcomes
Tear meniscus height (TMH)
Time frame: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
Conjunctival hyperemia (RS score)
Time frame: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
Meibomian gland score (meiboscore)
Time frame: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
MMP-9 detection
Time frame: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
LTA
Time frame: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Results publication: PubMed 35118029Tao Z, Wang J, Zhu M, Lin Z, Zhao J, Tang Y, Deng H. Does Orthokeratology Wearing Affect the Tear Quality of Children? Front Pediatr. 2022 Jan 18;9:773484. doi: 10.3389/fped.2021.773484. eCollection 2021.
- Results publication: PubMed 36569150Hui W, Xiao-Feng H, Song-Guo L, Jing-Jing W, Xuan H, Yong T. Application of orthokeratology on myopia control and its effect on ocular surface and meibomian gland function in Chinese myopic adolescents. Front Med (Lausanne). 2022 Dec 8;9:979334. doi: 10.3389/fmed.2022.979334. eCollection 2022.
- Results publication: PubMed 32000988Yan ZP. Dry eye symptoms and signs in children wearing OK lenses for six months in China. J Fr Ophtalmol. 2020 Mar;43(3):211-215. doi: 10.1016/j.jfo.2019.07.029. Epub 2020 Jan 27.
- Results publication: PubMed 23109740Fricke TR, Holden BA, Wilson DA, Schlenther G, Naidoo KS, Resnikoff S, Frick KD. Global cost of correcting vision impairment from uncorrected refractive error. Bull World Health Organ. 2012 Oct 1;90(10):728-38. doi: 10.2471/BLT.12.104034. Epub 2012 Jul 12.
- Results publication: PubMed 21212181Kakita T, Hiraoka T, Oshika T. Influence of overnight orthokeratology on axial elongation in childhood myopia. Invest Ophthalmol Vis Sci. 2011 Apr 6;52(5):2170-4. doi: 10.1167/iovs.10-5485.
- Results publication: PubMed 27464993He M, Du Y, Liu Q, Ren C, Liu J, Wang Q, Li L, Yu J. Effects of orthokeratology on the progression of low to moderate myopia in Chinese children. BMC Ophthalmol. 2016 Jul 27;16:126. doi: 10.1186/s12886-016-0302-5.
- Results publication: PubMed 31378996Nti AN, Berntsen DA. Optical changes and visual performance with orthokeratology. Clin Exp Optom. 2020 Jan;103(1):44-54. doi: 10.1111/cxo.12947. Epub 2019 Aug 4.
- Results publication: PubMed 30805209Wang X, Li J, Zhang R, Li N, Pang Y, Zhang Y, Wei R. The Influence of Overnight Orthokeratology on Ocular Surface and Meibomian Gland Dysfunction in Teenagers with Myopia. J Ophthalmol. 2019 Jan 21;2019:5142628. doi: 10.1155/2019/5142628. eCollection 2019.
- Results publication: PubMed 32359968Yang L, Zhang L, Jian Hu R, Yu PP, Jin X. The influence of overnight orthokeratology on ocular surface and dry eye-related cytokines IL-17A, IL-6, and PGE2 in children. Cont Lens Anterior Eye. 2021 Feb;44(1):81-88. doi: 10.1016/j.clae.2020.04.001. Epub 2020 Apr 30.
- Results publication: PubMed 35223920Yu H, Yuan Y, Wu W, Zeng W, Tong L, Zhang Y, Feng Y. Orthokeratology Lens Wear for 2 Years in Children Did Not Alter Tear Film Lipid Thickness by Non-Invasive Interferometry. Front Med (Lausanne). 2022 Feb 10;9:821106. doi: 10.3389/fmed.2022.821106. eCollection 2022.
- Results publication: PubMed 35331178Lee J, Hwang G, Ha M, Kim HS, Han K, Na KS. Evaluation of the meibomian glands using the tear interferometer wearing orthokeratology lenses. BMC Ophthalmol. 2022 Mar 24;22(1):133. doi: 10.1186/s12886-022-02365-3.
- Derived from this study: PubMed 39323780Song Y, Chen J, Qin G, Xu L, He W, Yu S, Pazo EE, He X. A protocol for a single center, randomized, controlled trial assessing the effects of spectacles or orthokeratology on dry eye parameters in children and adolescents. Heliyon. 2024 Sep 12;10(18):e37779. doi: 10.1016/j.heliyon.2024.e37779. eCollection 2024 Sep 30.
- Individual participant dataSharing planned: Yes. The study's findings will be shared regardless of the effect's direction. All possible beneficiaries of the research, including patients, carers, family, doctors, advisory boards, and medical boards, will receive trial data. Publications in high-impact, open-access medical journals and talks at national and international medical conferences will serve this purpose.
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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.
Emmanuel Eric E Pazo, PHD study chair
He Eye Hospital, Shenyang, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthokeratology and Spectacles in people with Dry Eye Disease, run by He Eye Hospital at 1 site 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 1 inclusion and 1 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 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Emmanuel Eric E Pazo, PHD (0086-18612782131, ericpazo@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-invasive tear break-up time (time frame: Day-0 (baseline), 1-month ,3-month,6-month and 12-month.). The study lists 3 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 NCT06023108, which also lists 12 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 13 Sep 2023.