Performance Evaluation of Dream OCT: AP Study (NCT07355491) | Clinical Trial Compass
CompletedNot Applicable
Performance Evaluation of Dream OCT: AP Study
United States120 participantsStarted 2025-12-16
Plain-language summary
This study will evaluate the clinical performance of a new swept-source OCT imaging device, the VG200D, and to evaluate substantial equivalence with a predicate device, the Cirrus 5000. Clinical performance will be assessed through an agreement and precision analysis of OCT measurement parameters.
Who can participate
Age range
22 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
. Subjects 22 years of age or older on the date of informed consent
. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
. Subjects with normal eye examinations in both eyes on the date of the study visit as observed with a 90 diopter lens
. BCVA 20/40 or better (each eye) on the date of the study visit
Exclusion criteria
. Subjects unable to tolerate ophthalmic imaging
. Subjects not able to obtain acceptable OCT images due to ocular media opacity or other reasons
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
OCT Measurement Agreement between OCT devices and measurement Precision Results
Timeframe: This study will last approximately 6 months
. Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
. Presence of any ocular pathology except for cataract in either eye
. Subjects 22 years of age or older on the date of informed consent
. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
. BCVA 20/40 or better in the study eye
. History of Visual field defects within the previous year from the study visit or measured the day of the study visit consistent with glaucomatous optic nerve damage with at least one of the following two findings: