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‘Off the shelf' Toric Intraocular Lenses (TIOLs) for patients in the National Health Service: Preliminary Data of a Randomised Controlled Trial.

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First Author: K.Naderi UK

Co Author(s):    S. Low   M. Bhogal   V. Wagh   S. Robbie   A. Ritchie   D. O'Brart     

Abstract Details

Purpose:

TIOL implantation at the time of cataract surgery is associated with additional time and financial expenditure, which is important in a public healthcare setting. The ability to access an in-house bank of TIOLs can reduce such costs, allowing public healthcare patients routine access to TIOLs and their associated visual and refractive benefits. We present our preliminary data of a randomised controlled trial comparing outcomes with ‘fully-tailored’ TIOLs, and an ‘off the shelf’ approach with 2.00 or 4.00 dioptre cylinder (DC) corrections only with additional opposite clear corneal incisions.

Setting:

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

Methods:

Patients with pre-existing regular corneal astigmatism of 1.50 dioptres or more were recruited. 15 patients have been randomised to the fully tailored (FT) group, with 11 patients in the ‘off the shelf’ (OTS) group. Primary outcomes include uncorrected distance visual acuity (UDVA) (LogMAR), best corrected visual acuity (BCVA), residual refractive astigmatism (dioptres). Secondary outcome measures include validated patient reported outcome measures (PROMs) using CATPROM and EQ-5D-3L questionnaires, and adverse events. Follow up was at four weeks.

Results:

Mean UDVA (+/-SD) was 0.15 (0.098) in the FT group and 0.09 (0.12) in the OTS group (p=0.21). Mean BCVA was 0.017 (0.06) in the FT group and -0.05 (0.06) in the OTS group (p=0.01). Mean pre-operative astigmatic cylinders (dioptres) were 2.38 (0.59) and 2.22 (0.54) in the FT and OTS groups, respectively. Mean post-operative refractive cylinder was 0.9 (0.49) in the FT group, and 0.61 (0.36) in the OTS group (p=0.11). The mean vector difference was 0.90 (0.49) in the FT group and 0.61 (0.36) in the OTS group (p=0.11). There were no differences in PROMs between groups.

Conclusions:

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 on 26 eyes suggests that it may not be inferior to using fully tailored TIOLs.

Financial Disclosure:

... receives consulting fees, retainer, or contract payments from a competing company, ... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented