ESCRS - FP31 - ‘OFF THE SHELF’ TORIC INTRAOCULAR LENSES (TIOLS) FOR PATIENTS IN THE NATIONAL HEALTH SERVICE: PRELIMINARY DATA OF A RANDOMISED CONTROL TRIAL

‘OFF THE SHELF’ TORIC INTRAOCULAR LENSES (TIOLS) FOR PATIENTS IN THE NATIONAL HEALTH SERVICE: PRELIMINARY DATA OF A RANDOMISED CONTROL TRIAL

Published 2022 - 26th ESCRS Winter Meeting

Reference: FP31 | Type: Abstracts | DOI: 10.82333/wy64-1w95

Authors: Khayam Naderi* 1 , Sancy Low 2 , Vijay Wagh 2 , Mani Bhogal 2 , Ailsa Ritchie 3 , Scott Robbie 3 , Chris Hammond 1 , Moin Mohamed 3 , Nick Stanojcic 2 , Elodie Azan 2 , Lily Lai 3 , Chris Hull 4 , David O'Brart 5

1Ophthalmology ,St.Thomas' Hospital,London,United Kingdom;Diabetes and Nutritional Sciences,King's College London,London,United Kingdom, 2Ophthalmology,St.Thomas' Hospital,London,United Kingdom, 3Ophthalmology ,St.Thomas' Hospital,London,United Kingdom, 4Eye Vision,City University,London,United Kingdom, 5Ophthalmology,St.Thomas' Hospital,London,United Kingdom;Diabetes and Nutritional Sciences,King's College London,London,United Kingdom

Purpose

TIOL implantation is associated with additional chair time and financial expenditure, which is important in a public healthcare setting. We present preliminary data of a randomised controlled trial comparing a ‘fully-tailored’ (FT) TIOLs, and an ‘off the shelf’ (OTS) approach with 2.00 or 4.00 dioptre cylinder (DC) corrections with additional opposite clear corneal incisions. 

Setting

Single-centre, prospective single-masked randomised case-controlled trial in a university hospital. 

Methods

Patients with pre-existing regular corneal astigmatism of 1.50 dioptres or more were recruited. 32 patients have been randomised to the FT group, with 34 patients in the OTS group. Primary outcomes include uncorrected distance visual acuity (UDVA), best corrected visual acuity (BCVA), post-operative refractive cylinder (RC).  Secondary outcomes include validated patient reported outcome measures (PROMs) using CATPROM and EQ-5D-3L questionnaires, and adverse events. Follow up was at four weeks and six months.



Results

At 4 weeks, mean UDVA(+/-SD) was 0.17 (0.15) in the FT (n=32) and 0.13 (0.12) in the OTS (n=34) group (p=0.22). Mean BCVA was 0.0022 (0.091) in FT and 0.018 (0.11) in OTS (p=0.52). Mean RC was 0.87 (0.53) in FT, and 0.64 (0.35) in OTS (p=0.044). Mean vector difference (MVC) was 0.87 (0.53) in FT and 0.64 (0.35) in OTS (p=0.044). There were no differences in PROMs between groups. In those patients who have thus far reached 6-month follow-up (FT (n=16) and OTS (n=19)), mean UDVA(+/-SD) was 0.14 (0.16) in the FT and 0.14 (0.15) in the OTS group (p=0.96). Mean BCVA was 0.024 (0.11) in FT and 0.0032 (0.10) in OTS (p=0.57). Mean RC was 0.69 (0.31) in FT, and 0.87 (0.46) in OTS (p=0.19). MVC was 0.69 (0.31) in FT and 0.87 (0.45) in OTS (p=0.19). Patients in the OTS group (-7.13(2.36)) had better CATPROM-5 scores compared to the FT group (-4.59 (2.19)) at six months (p=0.0024) but there was no difference in EQ-5D-3L outcomes. 

Conclusion

The use of ‘off the shelf’ 2.00DC and 4.00DC TIOLs with additional opposite clear corneal incisions may improve UVA and allow patients to achieve spectacle independence for distance vision. Our preliminary data suggests that it may not be inferior to using fully tailored TIOLs.