Patching for Lazy Eye: Trial to Evaluate Daily Patching Amounts

This study has been completed.
Sponsor:
Collaborator:
Imperial College London
Information provided by:
City University, London
ClinicalTrials.gov Identifier:
NCT00274664
First received: January 9, 2006
Last updated: NA
Last verified: December 2005
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Amblyopia
Device: 6 hours occlusion by patching
Device: 12 hours occlusion by patching
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised Occlusion Treatment of Amblyopia Study (ROTAS): Trial of Maximal Vs Substantial Doses of Occlusion to Evaluate Visual Outcome for Children With Amblyopia

Resource links provided by NLM:


Further study details as provided by City University, London:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 100
Study Start Date: February 2002
Estimated Study Completion Date: May 2005
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.

  Eligibility

Ages Eligible for Study:   3 Years to 8 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274664

Locations
United Kingdom
St Marys Hospitals
London, Greater London, United Kingdom, W2 1NY
Hillingdon Hospital
London, Middlesex, United Kingdom, UB8 3NN
Sponsors and Collaborators
City University, London
Imperial College London
Investigators
Principal Investigator: Merrick J Moseley, PhD City University, London
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00274664     History of Changes
Other Study ID Numbers: ROTAS-091206, Fight for Sight: 20500
Study First Received: January 9, 2006
Last Updated: January 9, 2006
Health Authority: United Kingdom: National Health Service

Keywords provided by City University, London:
Amblyopia
Occlusion dose monitoring
Refractive adaptation
Dose-response

Additional relevant MeSH terms:
Amblyopia
Brain Diseases
Central Nervous System Diseases
Eye Diseases
Nervous System Diseases
Neurologic Manifestations
Sensation Disorders
Signs and Symptoms
Vision Disorders

ClinicalTrials.gov processed this record on October 23, 2014