BMJ  2007;335:707 (6 October), doi:10.1136/bmj.39301.460150.55 (published 13 September 2007)

Research

Objectively monitored patching regimens for treatment of amblyopia: randomised trial

Catherine E Stewart, department of health research fellow1, David A Stephens, professor of statistics2, Alistair R Fielder, professor of ophthalmology1, Merrick J Moseley, senior lecturer1, ROTAS Cooperative

1 Department of Optometry and Visual Science, City University, London EC1V 0HB, 2 Department of Mathematics and Statistics, McGill University, Montreal, QC, Canada H3A 2K6

Correspondence to: M J Moseley m.j.moseley{at}city.ac.uk

Objectives To compare visual outcome in response to two prescribed rates of occlusion (six hours a day and 12 hours a day).

Design Unmasked randomised trial.

Setting Research clinics in two London hospitals.

Participants 97 children with a confirmed diagnosis of amblyopia associated with strabismus, anisometropia, or both.

Interventions: 18 week period of wearing glasses (refractive adaptation) followed by occlusion prescribed ("patching") for six or 12 hours a day.

Main outcome measures Visual acuity measured by logMAR letter recognition; objectively monitored rate of occlusion (hours a day).

Results The mean age of children at study entry was 5.6 (SD 1.5) years. Ninety were eligible for occlusion but 10 dropped out in this phase, leaving 80 children who were randomised to a prescribed dose rate of six (n=40) or 12 (n=40) hours a day. The mean change in visual acuity of the amblyopic eye was not significantly different (P=0.64) between the two groups (0.26 (95% confidence interval 0.21 to 0.31) log units in six hour group; 0.24 (0.19 to 0.29) log units in 12 hour group). The mean dose rates (hours a day) actually received, however, were also not significantly different (4.2 (3.7 to 4.7) in six hour group v 6.2 (5.1 to 7.3) in 12 hour group; P=0.06). The visual outcome was similar for those children who received three to six hours a day or more than six to 12 hours a day, but significantly better than that in children who received less than three hours a day. Children aged under 4 required significantly less occlusion than older children. Visual outcome was not influenced by type of amblyopia.

Conclusions Substantial (six hours a day) and maximal (12 hours a day) prescribed occlusion results in similar visual outcome. On average, the occlusion dose received in the maximal group was only 50% more than in the substantial group and in both groups was much less than that prescribed. Younger children required the least occlusion.

Trials registration Clinical Trials NCT00274664 [ClinicalTrials.gov] .


Add to CiteULike CiteULike   Add to Complore Complore   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us   Add to Digg Digg   Add to Reddit Reddit   Add to Technorati Technorati    What's this?

Related Article

Occlusion therapy for amblyopia
Sjoukje E Loudon and Huibert J Simonsz
BMJ 2007 335: 678-679. [Extract] [Full Text] [PDF]

This article has been cited by other articles:

  • Loudon, S. E, Simonsz, H. J (2007). Occlusion therapy for amblyopia. BMJ 335: 678-679 [Full text]  

Rapid Responses:

Read all Rapid Responses

Occlusion treatment studies of amblyopia treatment are ambiguous.
Philip Lempert
bmj.com, 15 Oct 2007 [Full text]
Modern amblyopia management
Annegret H Dahlmann-Noor, et al.
bmj.com, 30 Oct 2007 [Full text]
Occlusion therapy – non-compliance issues
Sandra D Gawley, et al.
bmj.com, 21 Nov 2007 [Full text]



Student BMJ

Intimate examinations

Israeli students are refusing to perform intimate examinations on anaesthetised women without their informed consent.

www.student.bmj.com

Listen to the latest BMJ Interview