Macular Damage in Early Glaucoma and Progression (NCT02547740) | Clinical Trial Compass
CompletedNot Applicable
Macular Damage in Early Glaucoma and Progression
United States260 participantsStarted 2015-10
Plain-language summary
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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Glaucoma Group:
Inclusion Criteria:
* glaucomatous optic neuropathy (as defined in the American Academy of Ophthalmology Preferred Practice Pattern criteria)
Exclusion Criteria:
* late functional glaucomatous damage
* significant cataract
* previous ocular surgery (aside from uncomplicated cataract extraction with intraocular lens (IOL) implantation and/or trabeculectomy, LASIK or refractive surgeries)
* diabetic retinopathy with macular edema
* vein or artery occlusion
* exudative age-related macular degeneration or geographic atrophy
* 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)
* retinal detachment (current or post-surgery)
* retinitis pigmentosa
* significant epiretinal memberane
* significant kerotoconus
Healthy Group:
Inclusion 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
Exclusion Criteria:
* evidence of optic neuropathy
* evidence of clinically significant metabolic diseases (e.g. diabetes and hypotension)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.