Excimer Laser Surgery for Anisometropic Amblyopia

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.

Conditions

• Anisometropic Amblyopia
• Refractive Errors

Interventions

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.

Sponsors & Collaborators

• Pediatric Eye Disease Investigator Group

  collaborator NETWORK

• National Eye Institute (NEI)

  collaborator NIH

• Jaeb Center for Health Research

  lead OTHER

Principal Investigators

• Evelyn A Paysse, MD · Baylor College of Medicine

• David K Wallace, MD, MPH · Duke Eye Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

3 Years

Max Age

7 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-30

Primary Completion

2022-03-31

Completion

2024-03-31

FDA Device

Yes