Excimer Laser Surgery for Anisometropic Amblyopia

NCT03342235 | Withdrawn DMC FDA Device

• 2 other identifiers: ATS192U10EY011751
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 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

Keywords

Excimer Laser Surgery; Photorefractive Keratectomy; Anisometropic Amblyopia; Visual Acuity; Refractive Surgical Procedures; PRK

Outcome Measures

Primary Outcomes (1)

• Mean Change in Best Corrected Visual Acuity in the Amblyopic Eye

  Treatment group comparison of the change in Best-Corrected ATS-HOTV VA (BCVA) in the amblyopic eye at 8 months after randomization. ATS-HOTV = ATS single-surround HOTV testing protocol

  from randomization to the 8-month primary outcome visit

Secondary Outcomes (8)

• Randot Preschool Stereoacuity Outcomes by Treatment Group

  At 8 months after randomization

• Refractive Error Outcomes in Surgery Group

  At 7 months after randomization

• Visual Acuity Outcomes

  At 8 months

• Distribution of refractive error outcomes

  At 7 months after baseline

• Distribution in Randot Preschool stereoacuity level

  at baseline and 8 months

Study Arms (2)

Surgical Group

EXPERIMENTAL

Participants randomized to PRK surgery will be referred to a study surgical center. The participant will have a preoperative exam within 7 days prior to surgery and surgery within 60 days after randomization. Participants will continue prescribed 2 hours per day of patching between randomization and the day of surgery.

Procedure: Photorefractive Keratectomy (PRK); Device: Excimer Laser System

Non-surgical Control Group

ACTIVE COMPARATOR

For participants assigned to the non-surgical control group, patching will be prescribed for 2 hours per day with optical correction, and will continue until the 8-month primary outcome visit.

Other: Patching 2 hours per day

Interventions

Photorefractive Keratectomy (PRK) PROCEDURE

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.

Also known as: PRK Surgery

Surgical Group

Patching 2 hours per day OTHER

Patching prescribed 2 hours per day with continued refractive correction (with spectacles and/or contact lenses) as able.

Also known as: Patching

Non-surgical Control Group

Excimer Laser System DEVICE

Excimer Laser System for use in photorefractive keratectomy.

Surgical Group

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 3 to \<8 years
• Best-corrected amblyopic-eye VA using the ATS single-surround HOTV letter protocol (ATS-HOTV) meeting the following criteria:
• If age 3 to \<5 years, 20/80 to 20/800 (a re-test is required if the VA is 20/80)
• If age 5 to \<8 years, 20/63 to 20/800 (a re-test is required if the VA is 20/63)
• Note: For participants who require a re-test (as specified above), the better of the test and re-test acuities must meet the eligibility criteria for the amblyopic eye and will serve as the enrollment VA.
• Best-corrected fellow-eye VA meeting the following criteria by ATS-HOTV:
• If age 3 years, 20/50 or better
• If age 4 to 5 years, 20/40 or better
• If age 6 to 7 years, 20/32 or better
• 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):
• Refractive error in the amblyopic eye must be greater than the fellow eye.
• If the amblyopic eye is myopic, SE refractive error in the amblyopic eye between -3.00D and -12.00D, inclusive.
• If the amblyopic eye is hyperopic, SE refractive error in the amblyopic eye between +3.00D and +6.00D, inclusive, if \<=1.00D of astigmatism in the amblyopic eye; and between +3.00D and +5.00D, inclusive, if \>1.00D of astigmatism in the amblyopic eye.
• Astigmatism less than or equal to 3.50D in the amblyopic eye.

You may not qualify if:

• Non-refractive ocular cause for reduced VA in the amblyopic eye (example: cataract, posterior staphyloma, extensive myelinated nerve fiber layer, optic nerve anomaly, macular scar, corneal opacity); or any cause of previous form deprivation.
• Prior penetrating ocular surgery or injury
• Prior strabismus surgery within 60 days preceding enrollment
• Diagnosis of collagen vascular disease, Marfan syndrome, Ehlers-Danlos syndrome or other disorder of collagen synthesis
• Previous ocular condition that may predispose the eye to be treated for future complications, for example:
• Corneal disease (e.g., herpes simplex, herpes zoster keratitis, keratoconus or suspicion of keratoconus based upon family history, slit lamp exam, retinoscopy, or corneal topography (if able), recurrent erosion syndrome, corneal melt, or corneal dystrophy)
• Established diagnosis of glaucoma
• Any condition that, in the investigator's opinion, would interfere with or prolong corneal epithelial healing
• History of significant eye rubbing or dry eye symptoms
• History of retinopathy of prematurity resulting in macular ectopia
• Down syndrome (trisomy 21)

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• Pediatric Eye Disease Investigator Group: collaborator
• National Eye Institute (NEI): collaborator

MeSH Terms

Conditions

Amblyopia; Refractive Errors

Interventions

Photorefractive Keratectomy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Corneal Surgery, Laser; Laser Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Keratectomy; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures

Study Officials

• Evelyn A Paysse, MD

  Baylor College of Medicine

  STUDY CHAIR

• David K Wallace, MD, MPH

  Duke Eye Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Surgical Group: treatment with PRK and patching prescribed 2 hours per day with continued refractive correction (with spectacles and/or contact lenses) as able. o Surgery will be performed within 60 days of randomization * Non-surgical Control Group: patching prescribed 2 hours per day with continued refractive correction (with spectacles and/or contact lenses) as able.

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: November 14, 2017
• Study Start: June 1, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2024
• Last Updated: May 20, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available after publication of each primary manuscript.
• Access Criteria: Users accessing the data must enter an email address.