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Patching for Lazy Eye: Trial to Evaluate Daily Patching Amounts

NCT00274664 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2006-01-11

No results posted yet for this study

Summary

Amblyopia ('lazy eye') is the commonest visual disorder of childhood and is caused by an interruption to visual development. Occlusion of the better eye by patching is the mainstay of treatment, so forcing use, of the affected eye. We have little understanding of how much treatment is required for improvement, so occlusion may continue for many months. This is both demanding for the child and family as a whole. Treatment outcome is frequently unsatisfactory. Compliance is often poor, thus we do not know precisely how much treatment the child actually receives or how much is required.

To overcome this, we have designed an instrument that permits us to measure occlusion: an occlusion dose monitor (ODM) which provides an objective record of how much occlusion a child actually receives. Recently we have observed that 75% of improvement induced by occlusion occurs in the first four weeks of treatment. In this study we explore the possibility that by intensive treatment the period of amblyopia therapy can be shortened - i.e. treatment will be more efficient, more effective, and more 'family-friendly'. The study hypothesis is that 12 hours/day of patching is more effective than 6 hours/day.

Conditions

  • Amblyopia

Interventions

DEVICE

6 hours occlusion by patching

DEVICE

12 hours occlusion by patching

Sponsors & Collaborators

  • Imperial College London

    collaborator OTHER

  • City, University of London

    lead OTHER

Principal Investigators

  • Merrick J Moseley, PhD · City, University of London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-02-28
Completion
2005-05-31

Countries

  • United Kingdom

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 NCT00274664 on ClinicalTrials.gov