Patching for Lazy Eye: Trial to Evaluate Daily Patching Amounts

NCT ID: NCT00274664

Last Updated: 2006-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2005-05-31

Brief 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.

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.

Conditions

Amblyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

6 hours occlusion by patching

Intervention Type: DEVICE

12 hours occlusion by patching

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Imperial College London

OTHER

Sponsor Role: collaborator

City, University of London

OTHER

Sponsor Role: lead

Principal Investigators

Merrick J Moseley, PhD

Role: PRINCIPAL_INVESTIGATOR

City, University of London

Locations

St Marys Hospitals

London, Greater London, United Kingdom

Hillingdon Hospital

London, Middlesex, United Kingdom

Countries

United Kingdom

References

Moseley MJ, Stewart CE, Fielder AR, Stephens DA; MOTAS cooperative. Intermediate spatial frequency letter contrast sensitivity: its relation to visual resolution before and during amblyopia treatment. Ophthalmic Physiol Opt. 2006 Jan;26(1):1-4. doi: 10.1111/j.1475-1313.2005.00343.x.

Reference Type: BACKGROUND

PMID: 16390475 (View on PubMed)

Stewart CE, Fielder AR, Stephens DA, Moseley MJ. Treatment of unilateral amblyopia: factors influencing visual outcome. Invest Ophthalmol Vis Sci. 2005 Sep;46(9):3152-60. doi: 10.1167/iovs.05-0357.

Reference Type: BACKGROUND

PMID: 16123414 (View on PubMed)

Stewart CE, Moseley MJ, Fielder AR, Stephens DA; MOTAS Cooperative. Refractive adaptation in amblyopia: quantification of effect and implications for practice. Br J Ophthalmol. 2004 Dec;88(12):1552-6. doi: 10.1136/bjo.2004.044214.

Reference Type: BACKGROUND

PMID: 15548811 (View on PubMed)

Stewart CE, Moseley MJ, Stephens DA, Fielder AR. Treatment dose-response in amblyopia therapy: the Monitored Occlusion Treatment of Amblyopia Study (MOTAS). Invest Ophthalmol Vis Sci. 2004 Sep;45(9):3048-54. doi: 10.1167/iovs.04-0250.

Reference Type: BACKGROUND

PMID: 15326120 (View on PubMed)

Stewart CE, Fielder AR, Stephens DA, Moseley MJ. Design of the Monitored Occlusion Treatment of Amblyopia Study (MOTAS). Br J Ophthalmol. 2002 Aug;86(8):915-9. doi: 10.1136/bjo.86.8.915.

Reference Type: BACKGROUND

PMID: 12140215 (View on PubMed)

Stewart CE, Moseley MJ, Fielder AR. Defining and measuring treatment outcome in unilateral amblyopia. Br J Ophthalmol. 2003 Oct;87(10):1229-31. doi: 10.1136/bjo.87.10.1229.

Reference Type: BACKGROUND

PMID: 14507754 (View on PubMed)

Wallace MP, Stewart CE, Moseley MJ, Stephens DA, Fielder AR; Monitored Occlusion Treatment Amblyopia Study (MOTAS) Cooperatives; Randomized Occlusion Treatment Amblyopia Study (ROTAS) Cooperatives. Compliance with occlusion therapy for childhood amblyopia. Invest Ophthalmol Vis Sci. 2013 Sep 17;54(9):6158-66. doi: 10.1167/iovs.13-11861.

Reference Type: DERIVED

PMID: 23882695 (View on PubMed)

Stewart CE, Stephens DA, Fielder AR, Moseley MJ; ROTAS Cooperative. Objectively monitored patching regimens for treatment of amblyopia: randomised trial. BMJ. 2007 Oct 6;335(7622):707. doi: 10.1136/bmj.39301.460150.55. Epub 2007 Sep 13.

Reference Type: DERIVED

PMID: 17855283 (View on PubMed)

Other Identifiers

Fight for Sight: 20500

Identifier Type: -

Identifier Source: secondary_id

ROTAS-091206

Identifier Type: -

Identifier Source: org_study_id