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AmblyopiaPhase 1NCT00274664

Patching for Lazy Eye: Trial to Evaluate Daily Patching Amounts

A Phase 1 study testing 6 hours occlusion by patching and 12 hours occlusion by patching in people with Amblyopia, run by City, University of London at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 3 to 8 yearsHealthy volunteers can take part
Conditions the study is for
Amblyopia
What is being tested?
6 hours occlusion by patching and 12 hours occlusion by patching
Type of treatment
Medical device
How many people
100 participants
Where
2 sitesUnited Kingdom
Study dates
Feb 2002to May 2005
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 8 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • St Marys Hospitals

    London, Greater London, W2 1NY

  • Hillingdon Hospital

    London, Middlesex, UB8 3NN

Other trials in United Kingdom

About this study

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

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.

Read the 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
Being tested
6 hours occlusion by patching, 12 hours occlusion by patching
Keywords
Amblyopia, Occlusion dose monitoring, Refractive adaptation, Dose-response
Medical subject headings
Amblyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 6 hours occlusion by patchingDevice

  • 12 hours occlusion by patchingDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jan 2006 (estimated)
  2. Study startFeb 2002
  3. Study completionMay 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00274664
Sponsor's protocol ID
ROTAS-091206
Other IDs
Fight for Sight: 20500
Status last verified
Dec 2005
First submitted
9 Jan 2006
Last updated
11 Jan 2006
Results posted
No

Publications

  • 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.

    PubMed 16390475

  • 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.

    PubMed 16123414

  • 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.

    PubMed 15548811

  • 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.

    PubMed 15326120

  • 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.

    PubMed 12140215

  • 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.

    PubMed 14507754

  • 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.

    PubMed 23882695

  • 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.

    PubMed 17855283

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 6 hours occlusion by patching and 12 hours occlusion by patching in people with Amblyopia, run by City, University of London at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00274664, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2006.

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