NCT02547740Completed
Macular Damage in Early Glaucoma and Progression
Structural and Functional Progression of Glaucomatous Damage to the Macula
Source: ClinicalTrials.gov · Last updated 14 May 2024
Brief summary (registry, in English)
Glaucoma is the leading cause of irreversible blindness worldwide. This study aims to test a new method that may allow earlier diagnosis of glaucoma and better ways to monitor if it is getting worse. There is scientific evidence that the macula, the central part of the retina, can be involved in very early stages of glaucoma. Glaucomatous damage to the macula is very prevalent and is often missed using conventional clinical tests. Relatively little is known about progression of early glaucoma damage and its effects on the macula. This project investigates the nature of progressive damage to the macula and proposes new methods to improve accuracy to detect clinically significant progression.The study will evaluate the nature of damage to the macula's structures through OCT imaging and eye function via visual field tests.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 260 (actual)
- First submitted
- 10 Sept 2015
- Start date
- 1 Oct 2015
- Primary completion date
- 18 Jan 2024
- Lead sponsor
- Columbia University
- Diseases
- Glaucoma
- NCT number
- NCT02547740
What you commit to
- Study type: Observational
- Participants enrolled: 260
- From 1 Oct 2015 to the primary completion date, 18 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous ocular surgery (aside from uncomplicated cataract extraction with intraocular lens (IOL) implantation and/or trabeculectomy, LASIK or refractive surgeries)
- retinal detachment (current or post-surgery)
Other illness
- evidence of clinically significant metabolic diseases (e.g. diabetes and hypotension)
Age
- exudative age-related macular degeneration or geographic atrophy
Other
- late functional glaucomatous damage
- significant cataract
- diabetic retinopathy with macular edema
- vein or artery occlusion
- macular hole or traction
- amblyopia
- uveitis
- non-open angle glaucoma (e.g. angle closure, traumatic, congenital glaucoma)
- severe myopia or hyperopia (refractive error greater than -6 or +6D, respectively)
- retinitis pigmentosa
- significant epiretinal memberane
- significant kerotoconus
- Healthy Group:
- evidence of optic neuropathy
Who the study is looking for
- glaucomatous optic neuropathy (as defined in the American Academy of Ophthalmology Preferred Practice Pattern criteria)
- best corrected visual acuity equal or better than 20/40
- normal biomicroscopy examination
- gonioscopically open angles
- Intraocular Pressure (IOP) lower than 22 mmHg
- normal and reliable 24-2 and 10-2 SAP results
Criteria the registry did not label
- Glaucoma Group:
Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CUIMC Harkness Eye Institute Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.