A Study Conducted to Evaluate the Conjunctiva and Tenon's Capsule Status of Healthy Subjects and in Participants With Neovascular Age-related Macular Degeneration (nAMD)/Diabetic Macular Edema (DME)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

736 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-31

Study Completion Date

2025-11-28

Brief Summary

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The purpose of this study is to obtain conjunctiva and tenon's capsule thickness measurements in vivo using spectral domain-optical coherence tomography (SD-OCT) in participants with nAMD/DME and age-matched healthy subjects.

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Detailed Description

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Conditions

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Neovascular Age-related Macular Degeneration Diabetic Macular Edema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Cohort A: nAMD/DME Participants

Participants with nAMD/DME will be enrolled in this cohort given, they meet the eligibility criteria. The SD-OCT test will be conducted for all participants in this cohort. Additionally, swept source optical coherence tomography (SS-OCT) will be performed on the first 50 participants.

No interventions assigned to this group

Cohort B: Healthy Subjects

Healthy subjects who meet the eligibility criteria will be enrolled in this cohort. The SD-OCT test will be conducted for all subjects in this cohort. Additionally, SS-OCT will be performed on the first 50 healthy subjects.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

For nAMD/DME participants:

\- Diagnosis of nAMD/DME

For healthy subjects:

\- Normal visual function

Exclusion Criteria

* Current or past treatment for glaucoma (only for healthy subjects)
* Dry eye disease except those treated only with artificial tears
* Ocular hypertension treated with hypotensive drugs
* Pterygium
* Strabismus
* Previous ocular surgery except cataract surgery
* Cataract surgery with scleral incision
* Current contact lens wearers
* Myopia with more than 6 diopters
* Corneal transplant
* History of ocular surface inflammation
* Active or recent conjunctivitis infection
* Pregnancy
* Participant who has already received an IVT injection in the superotemporal quadrant (only for nAMD/DME participants)

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes