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Determining the Efficacy of Full-time Occlusion Therapy in Severe Amblyopia at Different Ages

NCT02113709 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 115

Last updated 2014-04-15

No results posted yet for this study

Summary

Objective: To find out how much visual improvement is possible in severe amblyopia using full-time occlusion therapy with an eye patch and to see if improvement is influenced by the patient's age.

Methods: An interventional clinical trial of 115 consecutive cases with unilateral, severe amblyopia was conducted at a tertiary referral center from Jan 2010 to Oct 2012. Patients were divided into three age groups: 3-7 years (n= 38), 8-12 years (n=41), 13-35 years (n=36). After a complete ophthalmological examination by a single ophthalmologist, cases with organic visual loss were excluded; cases with previous part-time occlusion therapy that had failed were included in the study. Patients were given optimal refractive correction for a month, followed by full-time occlusion therapy along with near visual activities for 3-4 hours/day. The therapy was continued until maximum visual recovery was achieved (6/6 Snellen's). Therapy was gradually reduced and stopped. Patients were followed-up regularly for the next 18 months.

Conditions

  • Amblyopia
  • Strabismus

Interventions

DEVICE

Occlusion therapy by Eye Patch

The good eye was occluded by a stick-on eye patch to stimulate the amblyopic eye and its neural connections to learn to see again.

DEVICE

Occlusion therapy

To see how much improvement in visual acuity occurs by full-time occlusion therapy.

Sponsors & Collaborators

  • Mughal Eye Trust Hospital

    lead OTHER

Principal Investigators

  • Sameera Irfan, FRCS · Mughal Eye Trust Hospital, Lahore, Pakistan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-10-31
Completion
2014-06-30

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02113709 on ClinicalTrials.gov