OCT in Diagnosis of Irregular Corneas (NCT03504800) | Clinical Trial Compass
RecruitingNot Applicable
OCT in Diagnosis of Irregular Corneas
United States445 participantsStarted 2018-05-01
Plain-language summary
This main goal of this study is to improve the detection, classification, monitoring, and treatment of irregular corneas due to keratoconus, warpage, dry eye, scar, stromal dystrophies, and other corneal conditions.
The primary goal will be achieved by using optical coherence tomography (OCT) to:
1. Develop an OCT-based system to classify and evaluate corneal-shape irregularities.
2. Develop OCT metrics for more sensitive detection of keratoconus progression.
3. Develop OCT-and-topography guided phototherapeutic keratectomy (PTK) for irregular corneas.
Who can participate
Age range
14 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.
Inclusion criteria
. CDVA ≥ 20/25 in the better eye; and both of the following in the worse eye
. Topography characteristic of keratoconus or pellucid marginal degeneration
. Contact lens use; and
. Topography irregularities
. Symptoms of dry eye documented by Ocular Surface Disease Index (OSDI) questionnaire score ≥ 30; and
. Topography irregularities
. Presence of punctate epithelial erosion on exam with surface staining
. Aqueous deficiency or evaporative dry eye
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
Develop OCT-based system to classify and evaluate corneal-shape irregularities
Timeframe: 1 day
2
Develop OCT-based system to classify and evaluate corneal-shape irregularities
Timeframe: 1 day
3
Develop OCT metrics for more sensitive detection of keratoconus progression
Timeframe: 4 year
4
Develop OCT metrics for more sensitive detection of keratoconus progression
Timeframe: 4 year
5
Develop OCT- and topography-guided phototherapeutic keratectomy (PTK) for irregular corneas
Timeframe: 1 year
6
Develop OCT- and topography-guided phototherapeutic keratectomy (PTK) for irregular corneas