A Randomized Trial to Evaluate Sequential vs Simultaneous Patching

Conditions

• Amblyopia

Eligibility Criteria

Sex

ALL

Age

3 Years - 13 Years

Healthy Volunteers

Not accepted

Interventions

• Patching — OTHER
  Procedure in which the eye is covered utilizing a patch to increase the strength of the uncovered eye.
• Glasses — OTHER
  Eye Glasses are created and worn by patient to improve vision

Study Details

A randomized trial to determine whether simultaneous treatment with spectacles and patching has an equivalent VA outcome compared with sequential treatment, first with spectacles alone followed by patching (if needed), for previously untreated amblyopia in children 3 to \<13 years of age.

Key Dates

Start date

Dec 8, 2020

Status verified

Feb 2026

Primary completion

May 1, 2028

Completion

May 1, 2028

Study Design

Enrollment

544 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Sequential treatment
  full-time spectacle correction first, with subsequent patching for 2 hours per day/7 days per week only if needed (no improvement (stable/worsening) and residual)
• Experimental: Simultaneous treatment
  full-time spectacle correction and part-time patching for 2 hours per day/7 days per week

Primary Outcome Measure

Mean Change in Amblyopic Eye logMAR distance Visual Acuity [ Time Frame: 56 weeks ]

Central Contacts

• Raymond T Kraker, MSPH
  813-975-8690
  [email protected]
• Brooke P Fimbel
  813-975-8690

Locations (68)

Find similar trials in Birmingham, AL

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