CompletedNot Applicable

Evaluation of the Precision of the Microperimetry Function of the Spectral OCT/SLO

United States32 participantsStarted 2012-10

Plain-language summary

To conduct a precision study to assess the microperimetry function of the Spectral OCT/SLO. The study will assess variability across measurements taken by three different operator-device configuration across clinical sites, variability between subjects within a given operator-device configuration, and variability within a subject for a single operator-device configuration.

Who can participate

Age range

21 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: * Subject must be 21 years of age or older. * Subjects recruited to Cohort 1 will have no known retinal disease except for refractive errors (-7.5 D to +7.5 diopters).Subjects who are recruited to Cohort 2 will have one or more of the following retinal pathologies: early and intermediate Age-Related Macular Degeneration, Geographic Atrophy, Diabetic Retinopathy (mild, moderate, severe), Macular Edema secondary to Diabetes, Retinal Vein Occlusion, Central Serous Retinopathy, Pattern Dystrophy, Epiretinal Membrane or Macular Hole. * Subjects who have signed an informed consent form. * Subjects who can comply with the protocol. Exclusion Criteria: * Subjects younger than 21 years of age. * Subjects who cannot comply with the protocol. * Subjects who cannot complete the Simple Test procedures * Subjects who are not available to be testing 3 times during the day (Morning, Mid - Day, and Afternoon). * Subjects with visual acuity worse than 20/100 (Best Corrected). * Subjects with dense media opacities. * Ocular surgery anticipated on the day of the study visit.

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

Standard Deviation and Mean Test Results of Normal and With Pathology Participants Taken by 3 Different Operator-device Configurations

Timeframe: 1 Month

Repeatability of Microperimetry Tests in Normal and With Pathology Participants Based on 3 Microperimetry Tests Taken for Each Participant for a Given Operator-device Combination.

Timeframe: 1 Month

Trial details

NCT IDNCT01692938

SponsorOptos, PLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2012-11

Results submitted2013-07-19

View on ClinicalTrials.gov More Age-Related Macular Degeneration trials

Plain-language summary

Who can participate

Age range

21 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.

What they're measuring

Standard Deviation and Mean Test Results of Normal and With Pathology Participants Taken by 3 Different Operator-device Configurations

Timeframe: 1 Month

Repeatability of Microperimetry Tests in Normal and With Pathology Participants Based on 3 Microperimetry Tests Taken for Each Participant for a Given Operator-device Combination.

Timeframe: 1 Month