Excimer Laser Surgery for Anisometropic Amblyopia — ATS19  

Refractive Errors Clinical Trial

Official title: Excimer Laser Surgery for Anisometropic Amblyopia

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Amblyopia
• Anisometropic Amblyopia
• Refractive Errors

• NCT number: NCT03342235
• Study type: Interventional
• Source: Jaeb Center for Health Research
• Status: Withdrawn
• Phase: N/A
• Start date: June 2020
• Completion date: March 2024