Photorefractive Keratectomy for Severe Anisometropia and Isoametropia Associated With Amblyopia

Launched by BAYLOR COLLEGE OF MEDICINE · Jul 26, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a surgical procedure called photorefractive keratectomy (PRK) to see if it can help improve vision in children with severe eye conditions like anisometropia (where the two eyes have significantly different refractive errors) and amblyopia (often known as "lazy eye"). The goal is to find out if PRK can provide better long-term vision for children aged 2 to 17 who have not responded to standard treatments for at least six months.

To be eligible for the trial, children must have significant differences in their vision that meet specific measurements, such as having a certain degree of nearsightedness, farsightedness, or astigmatism in both eyes. Participants can expect to undergo the PRK procedure, which uses a special laser to reshape the eye's surface, potentially leading to improved eyesight. It's important to note that children with certain eye conditions or previous issues affecting the cornea may not qualify for this trial. Overall, this study aims to provide new insights into how to better treat severe refractive errors in children, ultimately helping them achieve clearer vision.

Gender

ALL

Eligibility criteria

• • 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