Objectively monitored patching regimens for treatment of amblyopia: randomised trial.

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.