Photorefractive Keratectomy for Severe Anisometropia and Isoametropia Associated With Amblyopia (NCT03610997) | Clinical Trial Compass
TerminatedNot Applicable
Photorefractive Keratectomy for Severe Anisometropia and Isoametropia Associated With Amblyopia
Stopped: Participants no longer receiving intervention
United States200 participantsStarted 2001-01-01
Plain-language summary
Photorefractive keratectomy (PRK) with excimer laser has been used successfully to treat myopia, hyperopia, and astigmatism in adults for over 35 years. Children with high refractive errors that go untreated will develop severe amblyopia. PRK can normalize high refractive errors and potentially improve the visual acuity in affected children. The purpose of this study is to investigate whether children with high anisometropia or isoametropia with amblyopia that are nonresponsive to standard therapy and receive PRK develop better longterm visual acuity.
Who can participate
Age range
2 Years – 17 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:.
* Children aged 2 to 17 with significant anisometropia or isoametropia and amblyopia that have failed traditional treatment for at least 6 months.
* Anisometropic group:
* The anisometropia must be at least 3.00 diopters.
* The amblyopic eye best corrected visual acuity must be at least 2 lines worse than the fellow eye in verbal children
* Isoametropic group
* Myopia must be at least -4.00 diopters in both eyes
* Hyperopia must be at least +4.00 diopters in both eyes
* Astigmatism must be at least +2.50 diopters in both eyes.
Exclusion Criteria:
* History of significant corneal abnormality that, in the investigator's opinion, may limit visual rehabilitation.
* History of known collagen disorder
* History of known corneal ectasia
* History of previous herpes simplex keratitis
* Corneal thickness of less than 450u
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.