Patching for Lazy Eye: Trial to Evaluate Daily Patching Amounts

January 9, 2006 updated by: City, University of London

Randomised Occlusion Treatment of Amblyopia Study (ROTAS): Trial of Maximal Vs Substantial Doses of Occlusion to Evaluate Visual Outcome for Children With Amblyopia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The identification and subsequent management of amblyopia are major consumers of health service resource, and within the hospital sector account for around 80-90% of visits to the children's eye service. Occlusion of the better eye is the mainstay of treatment and because we have little understanding of the dose-response relationship this may continue for many months and sometimes for many hundreds of hours. This is demanding for the child and family as a whole and yet the outcome is frequently unsatisfactory. Currently, there is no reliable data on the kinetics of visual improvement, so occlusion tends to be prescribed on an ad hoc basis. Recent pilot research has shown that 75% of the treatment-generated improvement occurs within the first 4 weeks when 6 hours/day occlusion is prescribed.

In this study we explore the possibility that by intensive treatment the period of amblyopia therapy can be shortened - i.e. made both more efficient and hopefully more effective. The purpose of the present study, the Randomized Occlusion Treatment of Amblyopia Study (ROTAS), is to compare two frequently employed patching regimens: 'substantial' (6 hrs/day) against 'maximal' (12 hrs/day) patching. Our experimental design incorporates objective occlusion monitoring and is able to discriminate the beneficial effect of refractive correction from that of occlusion. The study comprises three phases: 'baseline', 'refractive adaptation' and 'occlusion.' Our aim is to provide guidelines for patient management based, for the first time, on experimentally determined and statistically verifiable relationships between treatment and outcome.

Study Type

Interventional

Enrollment

100

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Greater London
      • London, Greater London, United Kingdom, W2 1NY
        • St Marys Hospitals
    • Middlesex
      • London, Middlesex, United Kingdom, UB8 3NN
        • Hillingdon Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 3 to 8 years of age;
  • Presence of anisometropia and/or strabismus;
  • inter-ocular acuity difference of at least 0.1 logMAR
  • parental consent

Exclusion Criteria:

  • history of previous occlusion therapy
  • ocular pathology
  • learning difficulties

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary outcome measure was logMAR visual acuity, measured 6-weekly for 18 weeks in refractive adaptation phase. In occlusion phase measured 2-weekly until no further gains

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

City, University of London

Collaborators

Imperial College London

Investigators

  • Principal Investigator: Merrick J Moseley, PhD, City, University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2002

Study Completion

May 1, 2005

Study Registration Dates

First Submitted

January 9, 2006

First Submitted That Met QC Criteria

January 9, 2006

First Posted (Estimate)

January 11, 2006

Study Record Updates

Last Update Posted (Estimate)

January 11, 2006

Last Update Submitted That Met QC Criteria

January 9, 2006

Last Verified

December 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROTAS-091206
  • Fight for Sight: 20500

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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