Repeatability and Reproducibility of Cirrus HD-OCT Measurements of Illumination Areas Under the R… (NCT01890187) | Clinical Trial Compass
CompletedNot Applicable
Repeatability and Reproducibility of Cirrus HD-OCT Measurements of Illumination Areas Under the Retinal Pigment Epithelium
United States85 participantsStarted 2010-11
Plain-language summary
The objective of this study is to determine the repeatability and reproducibility of the Cirrus HD-OCT measurement of illumination areas under the retinal pigment epithelium (RPE).
Who can participate
Age range
50 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.
Inclusion Criteria:
* Males or females 50 years of age and older diagnosed to have advanced dry AMD with geographic atrophy.
* Geographic atrophy lesions should:
* Not be greater than 5 mm at the widest diameter. The entire lesion(s) should fit into the 6x6 mm scan area of the Cirrus HD-OCT.
* Not be smaller than 1.25 mm2.
* Not be confluent with peri-papillary atrophy.
* Not be combined with other lesions such as CNV.
* Able and willing to make the required study visits.
* Able and willing to give consent and follow study instructions.
Exclusion Criteria:
* History of retinal surgery, laser photocoagulation, and/or radiation therapy to the eye.
* Evidence of other retinal diseases of the eye, including wet AMD, diabetic retinopathy, diabetic macular edema, or significant vitreomacular traction.
* Thick media opacity or inability to fixate that precludes obtaining acceptable scans.
* Concomitant use of hydrochloroquine or chloroquine.
* Unable to make the required study visits.
* Unable to give consent or follow study instructions.
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.
What they're measuring
1
Coefficient of variation for area of increased illumination under the RPE (mm^2)