Miniature lens system implantation for advanced age-related macular degeneration

4.1 In a non-randomised comparative study of 217 patients with age-related macular degeneration (AMD) comparing vision in an eye with an implanted telescope lens system with the fellow eye as control, 67% (128/192) of implanted eyes gained 3 or more lines in best-corrected distance visual acuity (BCDVA) compared with 13% (24/192) of fellow eyes at 1‑year follow-up (p<0.0001). At 2‑year follow-up, 60% (103/173) of implanted eyes had gained 3 or more lines in BCDVA compared with 10% (18/174) of fellow eyes (p<0.0001). Mean BCDVA improved by 3.5 lines in implanted eyes compared with 0.8 lines in fellow eyes (p<0.0001). At 5‑year follow-up, the mean BCDVA improvement from baseline (±standard deviation) was 2.4(±2.7) lines in all patients (n=76). The subgroup analysis, in which patients were stratified by age, showed that the improvement was 2.7(±2.7) lines in those aged 65 to 75 years and 2.1(±2.9) lines in those over 75 years.

4.2 In a case series of 13 eyes (10 patients) implanted with an intraocular lens system, the mean best-corrected visual acuity (BCVA) was 1.37(±0.34) logMAR preoperatively and 0.68(±0.19) logMAR at 1‑year follow-up (p<0.001). In a case series of 6 eyes (6 patients) implanted with an intraocular telescopic lens, the mean gain in distance acuity was 3.66(±1.88) lines and BCDVA had improved significantly at 6‑month follow-up (p=0.014).

4.3 In the non-randomised comparative study of 217 patients with AMD comparing vision in an eye with an implanted telescope lens system with the fellow eye as control, 68% (130/192) of implanted eyes gained 3 or more lines in best-corrected near visual acuity (BCNVA) compared with 33% (64/192) of fellow eyes at 1‑year follow-up (p<0.0001). Mean BCNVA improved by 3.2 lines in implanted eyes compared with 1.8 lines in fellow eyes (p<0.0001).

4.4 In the non-randomised comparative study of 217 patients, self-reported quality-of-life scores (assessed using the National Eye Institute's visual functioning questionnaire 25‑item scores [NEI-VFQ‑25]) improved by more than 7 points from baseline (p<0.01) on 7 of 8 relevant subscales (vision specific subscales and psychosocial vision targeted subscales), at 1‑year follow-up. Overall, the mean NEI-VFQ‑25 composite score improved significantly by 6.1(±14.4) points from baseline (p<0.0001). In the subgroup analysis for age stratification both age groups (65 to 75 years, and over 75 years) showed clinically significant improvement in quality of life from baseline in most subscales, but it was higher in those aged 65 to 75 years (5‑point change in individual subscale scores or composite scores is considered as clinically significant).

4.5 The specialist advisers listed key efficacy outcomes as best-corrected distance visual acuity, best-corrected near visual acuity, reading speed and improvement in quality of life.

4.6 Five commentaries from patients who had experience of this procedure were received, which were discussed by the committee.