NCT03342235

Excimer Laser Surgery for Anisometropic Amblyopia

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 3 Years – 7 Years
• Healthy volunteers: Not accepted

Summary

Study Objectives To compare the efficacy and safety of surgical treatment (PRK) versus non-surgical treatment of anisometropic amblyopia in children who have failed conventional treatment due to non-compliance or non-response. Synopsis of Study Design The study consists of two phases: 1. A Patching Run-In Phase during which all participants are treated for at least 8 weeks with continued refractive correction (with spectacles and/or contact lenses) and patching prescribed 42 hours per week (averaging 6 hours daily) until no further improvement over 2 consecutive visits at least 4 weeks apart or the vision no longer meets eligibility criteria. 2. A Randomized Trial Phase, beginning after no further VA improvement in the patching run-in phase and qualifying amblyopia is still present, during which the participant is assigned to either surgery with PRK and patching prescribed 2 hours per day or to non-surgical treatment with continued refractive correction (with spectacles and/or contact lenses) and patching prescribed 2 hours per day.

Detailed description

The study is evaluating the efficacy of surgical treatment with PRK versus non-surgical treatment of anisometropic amblyopia in children who have failed conventional treatment. The primary analysis will be a treatment group comparison of the change in BCVA in the amblyopic eye at the 8-month primary outcome visit. For participants wearing a contact lens, the BCVA will be the visual acuity tested in the contact lens rather than in spectacles (or trial frames).

Conditions

• Anisometropic Amblyopia
• Refractive Errors

Interventions

Type	Name	Description
PROCEDURE	Photorefractive Keratectomy (PRK)	Subjects randomized to refractive surgery will be referred to one of six study surgical centers (surgical centers are listed in Appendix B) to have photorefractive keratectomy (PRK) in the affected eye within 60 days after randomization.
OTHER	Patching 2 hours per day	Patching prescribed 2 hours per day with continued refractive correction (with spectacles and/or contact lenses) as able.
DEVICE	Excimer Laser System	Excimer Laser System for use in photorefractive keratectomy.

Timeline

• Start date: 2020-06-01
• Primary completion: 2022-03-01
• Completion: 2024-03-01
• First posted: 2017-11-14
• Last updated: 2020-05-20

Regulatory

• FDA-regulated device study