Clinical Evaluation of Patients With X-linked Retinoschisis (NCT02331173) | Clinical Trial Compass
CompletedNot Applicable
Clinical Evaluation of Patients With X-linked Retinoschisis
United States66 participantsStarted 2012-11
Plain-language summary
The purpose of this study is to evaluate subjects with X-linked retinoschisis in a clinical setting to collect data on disease progression.
Who can participate
Age range
7 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Main Study:
* Clinical diagnosis consistent with XLRS
* Documented disease causing RS1 mutation
* 7 years of age or older
* Able to provide informed consent/assent
* Male
CAI sub-study:
• Presence of maculoschisis
Exclusion Criteria:
Main Study:
• Other eye diseases that might affect the results (e.g. history of retinal detachment, glaucoma, cataracts that prohibit imaging, or any other eye pathology that in the opinion of the investigator would preclude enrollment)
CAI Sub-study:
Exclusion Criteria
* Already being treated with CAIs
* Previous documented failure to respond to CAI treatment
Any drug-specific contraindication/precaution listed below (from www.micromedex.com):
Topical Eye Drop Dorzolamide Hydrochloride
Contraindications:
• hypersensitivity to dorzolamide products, including sulfa allergies
Precautions:
* dorzolamide is a sulfonamide that is absorbed systemically, sulfonamide hypersensitivity reactions may occur
* angle-closure glaucoma
* concomitant use of oral carbonic-anhydrase inhibitors
* conjunctivitis and lid reactions reported with chronic administration
* moderate to severe renal (CrCl less than 30 mL/min) or hepatic insufficiency
* ocular infection or inflammation
* recent ocular surgery
Topical Eye Drop Brinzolamide
Contraindications:
• hypersensitivity to any component of the product, including sulfa allergies
Precautions:
* concomitant use of oral carbonic anhydrase inhibitors is not recommended
* contact lens…
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.