Off the Shelf’ Toric Intraocular Lenses to allow better access in Public Healthcare: A Randomised Control Study

Abstract

Abstract Purpose To compare fully tailored (FT) toric intraocular lens (TIOL) implantation with an ‘off the shelf’ (OTS) approach, with only 2.0 or 4.0 dioptre cylinder (D) powers and opposite clear corneal incisions (OCCI) to simplify TIOL implantation in public healthcare. Methods Forty-seven patients with corneal astigmatism of 1.50DC or more were randomised to the OTS and 44 to the FT group. Primary outcomes were uncorrected distance visual acuity (UDVA) (logMar), best-corrected distance visual acuity (BDVA) and post-operative refractive cylinder (RC). Secondary outcomes were patient reported outcome measures (PROMs) (CATPROM and EQ-5D-3L), and adverse events. Follow up was four weeks (4W) and six months (6M). Results At 4W, mean UDVA (+/-SD) was 0.14 (0.11) in the OTS and 0.15 (0.14) in the FT group (p = 0.65); mean BDVA was 0.02 (0.1) in OTS and 0.00 (0.085) in FT (p = 0.27); mean RC was 0.73D (0.39) in OTS, and 0.85D (0.49) in FT (p = 0.23). At 6M, mean UDVA was 0.16 (0.15) in OTS and 0.10 (0.13) in FT (p = 0.075); mean BDVA was 0.01 (0.10) in OTS and − 0.01 (0.09) in FT (p = 0.34); mean RC was 0.89D (0.50) in OTS and 0.84D (0.42) in FT (p = 0.59). There were no differences in PROMs between the groups. No cases required further surgery to reposition the TIOL. Conclusions The use of OTS 2.00D and 4.00D cylinder TIOLs with additional OCCI is not significantly inferior to using FT TIOLs. This may facilitate access to TIOL implantation in public healthcare settings.