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Dry Eye DiseaseNCT06218992

Corneal and Tear Film Changes in Chinese Patients With Type 2 Diabetes

An observational study of Dry Eye Disease and Tear Film, run by He Eye Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Diabetes mellitus has been associated with ocular surface damage and exacerbates dry eye disease (DED) pathology. To investigate clinical and inflammatory changes in the ocular surface of insulin-independent type II diabetic patients. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Dry Eye Disease, Tear Film, Corneal Nerve
How many people
80 participants
Where
1 siteChina
Study dates
30 Dec 2023to 31 Dec 2024
Phase
Observational
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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants will be recruited at the Department of Ophthalmology, HESH.

Who may be able to join

  • Participants are diagnosed with dry eye according to the TFOS DEWS II diagnostic criteria: (a) OSDI questionnaire ≥13, (b) Non-invasive tear breakup time (NITBUT) <10 s, (c) ocular surface staining >5 corneal spots, greater than nine conjunctival spots (The presence of two or more criteria was used to establish a positive DE diagnosis).
  • Age ≥ 18

Who cannot join

  • Active ocular infection, such as infectious, viral, chlamydial, or immunologic conjunctivitis
  • A history of ocular surgery that might affect the corneal or tear film, such as corneal refractive surgery, keratoplasty, cataract surgery, or ocular laser surgery
  • Long-term contact lens wear
  • Other ocular diseases being treated might affect the corneal or tear film: such as glaucoma, dacryocystitis, uveitis, and pterygium.

Trial locations and contacts

1 site in 1 country.

Guanghao Qin contact

+8618842664420

qinguanghao@hsyk.com.cn

China1 site, 1 recruiting

  • He Eye Hospital

    Shenyang, Liaoning, 110034

    Jiayan Chen, +8618304019060, cjy100009@outlook.com

    Recruiting

Other trials in China

About this study

Official title: Corneal and Tear Film Changes in Chinese Patients With Type 2 Diabetes: a Cross-sectional Controlled Study

Diabetes mellitus has been associated with ocular surface damage and exacerbates dry eye disease (DED) pathology. To investigate clinical and inflammatory changes in the ocular surface of insulin-independent type II diabetic patients. This cross-sectional control study will recruit 200 Type 2 diabetic patients and 200 age- and sex-matched subjects without DM.

Read the detailed description

Diabetes mellitus (DM) is a developing global health challenge due to the multiple complications associated with long-term hyperglycemia. Although diabetic retinopathy is the most prevalent and well-known ophthalmic consequence, diabetes also causes clinically significant effects on the ocular surface. Among the ocular surface diseases, dry eye disease (DED) is the most common. Multiple mechanisms, such as ocular surface and lacrimal gland inflammation, neurotrophic deficiency, and meibomian gland dysfunction (MGD), play significant roles.

A loss of tear film homeostasis characterizes DED. DM is one of the risk factors for DED; 47% of DM patients suffer from ocular surface damage due to negative alterations to the tear film, corneal thickness, corneal epithelium, corneal nerve, and corneal endothelium. It has been suggested that one or more of the following initial events may lead to alterations described in the tear film and ocular surface of patients with DM: a) chronic hyperglycemia, b) corneal nerve damage, and c) impairment on insulin action.

Previous studies have explored the association between DM and ocular surface dysfunction. However, ocular surface and tear film parameters in diabetic patients are lacking in the Chinese population. Moreover, corneal nerve damage and ocular surface inflammation have not been systematically evaluated. Our study aimed to investigate clinical and inflammatory changes in the ocular surface of insulin-independent type II diabetic patients in a Chinese population.

Keywords
dry eye, tear film
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06218992
Study groupRoleWhat they receive
Study groupType 2 diabetic patients
Control groupAge- and sex-matched subjects without DM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MMP-9

    MMP-9 was measured using an immunochromatography assay by collecting 1ul tear samples from the lateral canthus using a capillary tear collector. To assess the concentration of MMP-9 in the tear samples, a commercial reagent card (S05B, Seinda Biomedical Corporation, Guangdong, China) based on colloidal gold and immunochromatographic analysis was utilized. 1ul tear sample was placed in the sampling hole on the reagent card, followed by three drops of diluent in the dilution hole. The reagent card was loaded into the proprietary analyzer, and 15 minutes later, the MMP-9 concentration was measured

    Measured: Baseline

Secondary outcomes (13)

  1. Non-invasive tear break-up time

    Changes in 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: Baseline

  2. 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

    Measured: Baseline

  3. Quality of meibum grade

    Meibum quality will be assessed under a slit-lamp: Five meibomian gland in the middle parts of the eyelid will be assessed using a scale of 0 to 3 for each gland (0 represented clear meibum; 1 represented cloudy meibum; 2 represented cloudy and granular meibum; and 3 represented thick, toothpaste like consistency meibum).

    Measured: Baseline

  4. Expressibility of meibum grade

    Meibum expressibility will be assessed under a slit-lamp:

    Eight meibomian glands in the middle part will be evaluated on a scale of 0 to 3 (0 denoted that all glands expressible;

    1 denoted that 3 to 4 glands expressible; 2 denoted those 1 to 2 glands expressible; and 3 denoted that no glands were expressible). The overall score was computed using the mean scores of these eight glands.

    Measured: Baseline

  5. Conjunctivocorneal epithelial staining grade

    Conjunctivocorneal epithelial staining will be assessed under a slit-lamp:

    Conjunctivocorneal epithelial staining will be assess corneal and conjunctival epithelium damage. Double vital staining approach with two microliters of a preservative-free solution containing 1% lissamine green and 1% sodium fluorescein will be instilled in the conjunctival sac. The eye will be sectioned into three equal pieces (temporal conjunctiva, cornea, and nasal conjunctiva). Each region receives a maximum staining score of three points and a minimum of zero points. The combined scores from all three parts were then recorded on a scale ranging from 0 (normal) to 9 (severe)

    Measured: Baseline

  6. Tear Film Lipid Layer

    Tear Film Lipid Layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan).

    Measured: Baseline

  7. OSDI Score

    Chinese translated, and validated OSDI (Allergan Inc, Irvine, USA) version will beused 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: Baseline

  8. Tear meniscus height (TMH)

    Non-invasive first tear film breakup time using the Keratograph 5M (Oculus, Germany) topographer will be measured three times consecutively and the median value was recorded

    Measured: Baseline

  9. Corneal nerves and immune/inflammatory cells change

    HRT III RCM, (Heidelberg Engineering GmbH, Dossenheim, Germany) will be used to record corneal nerves and immune/inflammatory cells change.

    Measured: Baseline

  10. Retinal morphology

    A scanning laser ophthalmoscope (TRC-NW300, Topcon, Tokyo, Japan) will be used to examine and record the retinal morphology, and deep learning software will be used to analyze the vascular changes of the subjects.

    Measured: Baseline

  11. Central corneal sensitivity

    Central corneal sensitivity will be measured using a Cochet-Bonnet esthesiometer (Luneau Technology Operations, France), which stimulates the cornea with a nylon monofilament. The stiffness of the filament is adjusted by altering the length (0-6cm) of the filament with a slider on the side of the pen

    Measured: Baseline

  12. Corneal endothelium

    Corneal endothelium of all patients will be photographed by contactless specular microscopy (SM) device (EM-4000; Tomey Corporation, Japan) by the same observer. The unit of cell density was evaluated as mm2

    Measured: Baseline

  13. Thermal imaging: Ocular surface temperature (OST)

    All measurements were taken in the same room with controlled temperature and humidity. Prior to ocular thermography or other tests, participants were acclimatized to the room for 20 minutes. Morgan and colleagues described the following criteria for recording OST: The patients were instructed to blink normally, close their eyes for 3 seconds, and the first image was captured soon after the eyelids opened. The temperature was taken in the central cornea, which was defined as a circular area 4 mm in diameter in the middle of the cornea

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2024
  2. Study start30 Dec 2023
  3. Primary completion31 May 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06218992
Sponsor's protocol ID
DM2023
Status last verified
Nov 2023
First submitted
10 Jan 2024
Last updated
23 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Khan MAB, Hashim MJ, King JK, Govender RD, Mustafa H, Al Kaabi J. Epidemiology of Type 2 Diabetes - Global Burden of Disease and Forecasted Trends. J Epidemiol Glob Health. 2020 Mar;10(1):107-111. doi: 10.2991/jegh.k.191028.001.

    PubMed 32175717

  • Nentwich MM, Ulbig MW. Diabetic retinopathy - ocular complications of diabetes mellitus. World J Diabetes. 2015 Apr 15;6(3):489-99. doi: 10.4239/wjd.v6.i3.489.

    PubMed 25897358

  • Zhou Q, Yang L, Wang Q, Li Y, Wei C, Xie L. Mechanistic investigations of diabetic ocular surface diseases. Front Endocrinol (Lausanne). 2022 Dec 16;13:1079541. doi: 10.3389/fendo.2022.1079541. eCollection 2022.

    PubMed 36589805

  • Vieira-Potter VJ, Karamichos D, Lee DJ. Ocular Complications of Diabetes and Therapeutic Approaches. Biomed Res Int. 2016;2016:3801570. doi: 10.1155/2016/3801570. Epub 2016 Mar 28.

    PubMed 27119078

  • Bu Y, Shih KC, Tong L. The ocular surface and diabetes, the other 21st Century epidemic. Exp Eye Res. 2022 Jul;220:109099. doi: 10.1016/j.exer.2022.109099. Epub 2022 May 1.

    PubMed 35508213

  • Sima AA. Review: pathogenesis, progression, and therapeutic intervention of diabetic neuropathy. J Ocul Pharmacol. 1992 Summer;8(2):173-81. doi: 10.1089/jop.1992.8.173. No abstract available.

    PubMed 1506758

  • Alves Mde C, Carvalheira JB, Modulo CM, Rocha EM. Tear film and ocular surface changes in diabetes mellitus. Arq Bras Oftalmol. 2008 Nov-Dec;71(6 Suppl):96-103. doi: 10.1590/s0004-27492008000700018.

    PubMed 19274419

  • Kesarwani D, Rizvi SWA, Khan AA, Amitava AK, Vasenwala SM, Siddiqui Z. Tear film and ocular surface dysfunction in diabetes mellitus in an Indian population. Indian J Ophthalmol. 2017 Apr;65(4):301-304. doi: 10.4103/ijo.IJO_939_15.

    PubMed 28513494

  • Naik K, Magdum R, Ahuja A, Kaul S, S J, Mishra A, Patil M, Dhore DN, Alapati A. Ocular Surface Diseases in Patients With Diabetes. Cureus. 2022 Mar 22;14(3):e23401. doi: 10.7759/cureus.23401. eCollection 2022 Mar.

    PubMed 35495002

  • Bron AJ, de Paiva CS, Chauhan SK, Bonini S, Gabison EE, Jain S, Knop E, Markoulli M, Ogawa Y, Perez V, Uchino Y, Yokoi N, Zoukhri D, Sullivan DA. TFOS DEWS II pathophysiology report. Ocul Surf. 2017 Jul;15(3):438-510. doi: 10.1016/j.jtos.2017.05.011. Epub 2017 Jul 20.

    PubMed 28736340

  • Dammak A, Pastrana C, Martin-Gil A, Carpena-Torres C, Peral Cerda A, Simovart M, Alarma P, Huete-Toral F, Carracedo G. Oxidative Stress in the Anterior Ocular Diseases: Diagnostic and Treatment. Biomedicines. 2023 Jan 20;11(2):292. doi: 10.3390/biomedicines11020292.

    PubMed 36830827

  • Qin G, Chen J, Li L, Qi Y, Zhang Q, Wu Y, You Y, Yang L, Moore J, Xu L, He W, Yu S, Pazo EE, He X. Relationship between ocular surface pain and corneal nerve loss in dry eye diabetics: a cross-sectional study in Shenyang, China. BMJ Open. 2023 Sep 26;13(9):e076932. doi: 10.1136/bmjopen-2023-076932.

    PubMed 37751961

  • Bahabayi A, Yang N, Xu T, Xue Y, Ma L, Gu X, Wang Y, Jia K. Expression of Matrix Metalloproteinase-2,-7,-9 in Serum during Pregnancy in Patients with Pre-Eclampsia: A Prospective Study. Int J Environ Res Public Health. 2022 Nov 4;19(21):14500. doi: 10.3390/ijerph192114500.

    PubMed 36361378

Questions about this trial

What is this clinical trial studying?

An observational study of Dry Eye Disease and Tear Film, 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 2 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 23 Jan 2024. 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 Guanghao Qin (+8618842664420, qinguanghao@hsyk.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MMP-9 (time frame: Baseline). 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 NCT06218992, which also lists 13 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 23 Jan 2024.

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