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.
MethodsForty-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).
ResultsAt 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.A methodology where TIOLs with either 2.00DC or 4.00DC cylindrical corrections were implanted, with calculated residual astigmatism offset by OCCI, was not inferior in terms of visual and refractive outcomes, patient satisfaction and safety compared to the usual fully tailored TIOL correction.Using TIOLs with only 2.0DC and 4.0DC cylinder powers could facilitate access to TIOLs in the NHS/public health sector by allowing 'on site' TIOL banks, reducing costs in administrative time, lens transport and delivery, inventory wastage and giving manufacturers the opportunity to produce 2.00D and 4.00DC TIOLs in high volume, allowing possible reductions in production costs.