WithdrawnNot Applicable

Excimer Laser Surgery for Anisometropic Amblyopia

Stopped: Study not started due to lack of recruitment potential.

0Started 2020-06

Plain-language 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.

Who can participate

Age range3 Years – 7 Years

SexALL

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Inclusion criteria

✓. Age 3 to \<8 years
✓. Best-corrected amblyopic-eye VA using the ATS single-surround HOTV letter protocol (ATS-HOTV) meeting the following criteria:
✓. Best-corrected fellow-eye VA meeting the following criteria by ATS-HOTV:
✓. Best-corrected inter-ocular acuity difference ≥ 3 logMAR lines by ATS-HOTV
✓. Refractive error meeting the following criteria (based on a cycloplegic refraction that is not more than 4 months old):
✓. Prior to enrollment into the Patching Run-In Phase, must have had patching and/or optical penalization with atropine or Bangerter filters prescribed for at least 6 months and optical correction of refractive error prescribed for at least 6 months. Prior treatment does not have to be continuous. Compliance with prescribed treatment does not influence eligibility but the best effort at compliance is expected from both the patient and provider.
✓. Corneal thickness \>500 microns (\>510 microns within the previous 7 months, or corneal thickness between 500 and 510 microns within the last 2 months).
✓. Central corneal thickness must be enough to allow the treatment dose needed while leaving a residual corneal thickness of ≥ 375 microns.

Exclusion criteria

What they're measuring

Mean Change in Best Corrected Visual Acuity in the Amblyopic Eye

Timeframe: from randomization to the 8-month primary outcome visit

Trial details

NCT IDNCT03342235

SponsorJaeb Center for Health Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03

View on ClinicalTrials.gov More Anisometropic Amblyopia trials