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

January 22, 2024 updated by: He Eye Hospital

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110034
        • Recruiting
        • He Eye Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Study group
Type 2 diabetic patients
Control group
Age- and sex-matched subjects without DM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MMP-9
Time Frame: Baseline
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
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-invasive tear break-up time
Time Frame: Baseline
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.
Baseline
Conjunctival hyperemia (RS score)
Time Frame: Baseline
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
Baseline
Quality of meibum grade
Time Frame: Baseline
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).
Baseline
Expressibility of meibum grade
Time Frame: Baseline

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.
Baseline
Conjunctivocorneal epithelial staining grade
Time Frame: Baseline

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)
Baseline
Tear Film Lipid Layer
Time Frame: Baseline
Tear Film Lipid Layer interferometry will be assessed using DR-1 (Kowa, Nagoya, Japan).
Baseline
OSDI Score
Time Frame: Baseline
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
Baseline
Tear meniscus height (TMH)
Time Frame: Baseline
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
Baseline
Corneal nerves and immune/inflammatory cells change
Time Frame: Baseline
HRT III RCM, (Heidelberg Engineering GmbH, Dossenheim, Germany) will be used to record corneal nerves and immune/inflammatory cells change.
Baseline
Retinal morphology
Time Frame: Baseline
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.
Baseline
Central corneal sensitivity
Time Frame: Baseline
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
Baseline
Corneal endothelium
Time Frame: Baseline
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
Baseline
Thermal imaging: Ocular surface temperature (OST)
Time Frame: Baseline
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

He Eye Hospital

Investigators

  • Study Chair: Guanghao Qin, He Eye Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 30, 2023

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 23, 2024

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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