Enhanced low vision rehabilitation for people with age related macular degeneration: a randomised controlled trial

Abstract

Aim: To compare the effectiveness of three models of low vision rehabilitation for people with age related macular degeneration (AMD) referred for low vision rehabilitation (LVR): (a) an enhanced low vision rehabilitation model (ELVR) including supplementary home based low vision rehabilitation; (b) conventional low vision rehabilitation (CLVR) based in a hospital clinic; (c) CLVR with home visits that did not include rehabilitation (CELVR), intended to act as a control for the additional contact time with ELVR.

Method: A single centre parallel group randomised controlled trial in participants' homes and the low vision clinic, Manchester Royal Eye Hospital. People referred for LVR with a primary diagnosis of AMD and visual acuity worse than 6/18 in both eyes and equal to or better than 1/60 in the better eye. The main outcome measures were vision specific quality of life (QoL) (primary outcome, VCM1) and generic health related QoL (SF-36); psychological adjustment to vision loss; measured task performance; restriction in everyday activities; use of low vision aids (LVAs).

Results: 226 participants were recruited (median age 82 years); 194 completed the trial (86%). Except for SF-36 physical and mental component summary scores, arms did not differ significantly for any of the outcomes. Differences for the VCM1 were ELVR v CLVR, 0.06 (95% CI to 0.17 to 0.30, p = 0.60); ELVR v CELVR, 0.12 (95% CI to 0.11 to 0.34, p = 0.31); CELVR v CLVR, -0.05 (95% CI -0.29 to 0.18, p = 0.64). Differences for the SF-36 favoured CLVR compared to ELVR (ELVR v CLVR: physical = -6.05, 95% CI -10.2 to -1.91, p = 0.004; mental = -4.04, 95% CI -7.44 to -0.65, p = 0.02). At 12 months, 94% of participants reported using at least one LVA.

Conclusion: ELVR was no more effective than CLVR. Researchers should be wary of proposing new LVR interventions without preliminary evidence of effectiveness, given the manifest lack of effectiveness of the model of enhanced LVR evaluated in the trial.

Figure 1

Study design. ^aNon-refusals who were not recruited: two patients died soon after consenting; 10 consented too late (that is, had consented after attending their first clinic assessment); four consented but lived too far away from the hospital; researcher failed to visit one patient because of researcher’s ill health. ^bFirst clinic assessments: two patients in CLVR arm died before their appointments; two patients in ELVR arm did not attend, one because of ill health and one for unknown reasons; one patient in CELVR arm died before appointment and one did not attend because of ill health. ^cHome visits: these are shown in the diagram as they were scheduled. However, because some visits had to be rearranged, the sequence of the home visits varied with respect to second clinical assessment varied for some patients. ^dDuration of follow up: mean durations of follow up (number of days between the first home visit to measure baseline outcomes and the last home visit to measure outcomes after 12 months’ follow up) were 361, 364, and 362 in CLVR, ELVR, and CELVR arms, respectively.