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A randomised, prospective study of ‘off-the-shelf’ use of toric intraocular lenses for cataract patients with pre-existing corneal astigmatism in the NHS

Learning Objectives

Upon completion of this activity, participants will be able to:

  1. 1.

    Assess the efficacy of off-the-shelf use of 2-diopter cylinder correction toric intraocular lenses in cataract surgery for patients with preoperative corneal astigmatism of 2.00 D or more, based on a prospective randomised study.

  2. 2.

    Evaluate the safety and patient-reported outcomes of off-the-shelf use of 2-diopter cylinder correction toric intraocular lenses in cataract surgery for patients with preoperative corneal astigmatism of 2.00 D or more, based on a prospective randomised study.

  3. 3.

    Determine the potential suitability of off-the-shelf use of toric intraocular lenses for more widespread adoption by the National Health Service or other large public health programs, and other clinical implications of their efficacy and safety, based on a prospective randomised study.

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Credit hours

1.0

Release date: July 30, 2020

Expiration date: July 30, 2021

Post-test link: https://medscape.org/eye/posttest929021

Authors/Editors disclosure information

Sobha Sivaprasad, MD, has disclosed the following relevant financial relationships: served as an advisor or consultant for: Allergan, Inc.; Apellis; Bayer AG; Boehringer Ingelheim Pharmaceuticals, Inc.; Heidelberg Pharma GmbH; Novartis; Oculis; Optos; Oxurion; Roche. Served as a speaker or a member of a speakers bureau for: Allergan, Inc.; Bayer AG; Novartis Pharmaceuticals Corporation; Optos. Received grants for clinical research from: Allergan, Inc.; Bayer AG; Boehringer Ingelheim Pharmaceuticals, Inc.; Novartis Pharmaceuticals Corporation; Optos. Nick Stanojcic, BSc, MCOptom, FRCOphth, has disclosed no relevant financial relationships. Harry Roberts, MSc, FRCOphth, has disclosed the following relevant financial relationships: served as an advisor or consultant for: Alcon UK. Vijay Wagh, FRCOphth, has disclosed no relevant financial relationships. Bruno Zuberbuhler, PhD, FRCOphth, has disclosed no relevant financial relationships. David O'Brart, MD (Res), FRCOphth, FRCS, RefCert(RCOphth), has disclosed the following relevant financial relationships: received grants for clinical research from: Alcopn Inc., Rayner Ltd, Avedro Inc. Owns stock, stock options, or bonds from: Sparca Inc. Employed by a commercial interest: Sparca Inc.

Abstract

Background/objectives

To compare visual and refractive outcomes of monofocal intraocular lenses (IOLs) with limbal relaxing incisions (LRI) with ‘off-the-shelf’ use of toric IOLs (TIOLs), with a fixed 2-dioptre cylinder (DC) correction, for cataract patients with pre-existing corneal astigmatism in a public-sector setting.

Subjects/methods

Seventy-seven patients (77 eyes, first treated eye) with visually significant cataract and pre-operative corneal astigmatism ≥2.00 DC were randomised to receive either ‘off-the-shelf’ TIOLs, with a fixed 2.00 DC cylinder correction (39 eyes), or monofocal IOLs (38 eyes) with LRIs. The concept of fixing the cylindrical correction was to minimise costs, allow a full TIOL bank to be available and eliminate the need for individual TIOL ordering. Outcome measures were uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA) and refraction. Astigmatic changes were evaluated using the Alpins vector method.

Results

Mean UDVA improved from logMAR 0.88 (SD 0.56)[~20/150] pre-operatively to 0.18 (SD 0.19)[~20/30] post-operatively in TIOL group, versus 0.82 (SD 0.55)[~20/130] to 0.27 (SD 0.15)[~20/40] in monofocal/LRI group (P = 0.02; 95% CI: −0.17, −0.01). Mean CDVA improved from logMAR 0.40 (SD 0.26)[~20/50] to 0.01 (SD 0.12)[~20/20] in TIOL group, and 0.41 (SD 0.38)[~20/40] to 0.06 (SD 0.12)[~20/25] in LRI group (P = 0.07; 95% CI: −0.11, 0.01). Average post-operative refractive cylinder in TIOL group was 1.35 DC (SD 0.84 DC) and in LRI group 1.91 DC (SD 1.07 DC) (P = 0.01; 95% CI: −1, −0.12). Mean difference vector magnitude was 1.92 DC (SD 1.08 DC) in LRI group and 1.37 DC (SD 0.84 DC) in TIOL group (P = 0.02; 95% CI: 0.11, 0.99).

Conclusions

TIOLs with a fixed 2.00 DC correction during cataract surgery may improve UDVA, reduce post-operative cylinder and result in a more reliable astigmatic correction compared with monofocal IOLs with LRIs.

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Funding

This study was supported by a non-commercial grant from Rayner Ltd, UK. The sponsor or funding organisation had no role in the design or conduct of this research.

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Correspondence to Nick Stanojcic.

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Professor O’Brart has held non-commercial grants from Alcon Inc., USA, Rayner Ltd, UK and Avedro Inc, USA. The other authors declare that they have no conflict of interest.

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Ethical approval was granted by North West—Greater Manchester Central Research Ethics Committee (reference 11/NW/0428).

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Stanojcic, N., Roberts, H., Wagh, V. et al. A randomised, prospective study of ‘off-the-shelf’ use of toric intraocular lenses for cataract patients with pre-existing corneal astigmatism in the NHS. Eye 34, 1809–1819 (2020). https://doi.org/10.1038/s41433-020-0919-8

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