Astigmatism Management in Cataract Surgery With the AcrySof Toric Intraocular Lens

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Astigmatism

Treatments: Device: AcrySof Toric intraocular lens, model SN60TT; Device: AcrySof Monofocal IOL, model SN60AT

Study type: Interventional

Funder types: Other

Identifiers

NCT01075542

082099

Details and patient eligibility

About

The purpose of this study is to determine if Toric intraocular lens implantation in cataract surgery is a more efficient and cost-effective treatment of astigmatism than Monofocal intraocular lens implantation.

Full description

A recent innovation in cataract surgery consists of the introduction of toric intraocular lenses (IOLs) that can correct corneal astigmatism. It offers the opportunity for patients with substantial astigmatism to achieve optimal distance vision without using spectacles. Good near vision may subsequently be achieved with low-cost reading glasses. The current practice of non-toric IOL implantation in astigmatic patients warrants the use of expensive bifocal or multifocal spectacles with cylinder correction to achieve good distance and near vision.

Objective: The primary objective of this study is to compare spectacle independence for distance vision following toric IOL implantation and monofocal intraocular lens (IOL) implantation. The secondary objectives are to compare uncorrected distance vision, residual refractive astigmatism, quality of vision, wavefront aberrations, contrast sensitivity, complication profile, costs of postoperative spectacles and cost-effectiveness.

Study design: Multi-centre randomised clinical trial. Study population: 160 patients with regular corneal astigmatism of at least 1.25 diopters in both eyes who require bilateral cataract surgery.

Intervention: Cataract surgery with implantation of a toric IOL (AcrySof model SN60TT) or an monofocal IOL (AcrySof model SN60AT).

Enrollment: 86 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Bilateral cataract
• Bilateral corneal astigmatism (at least 1.25D)
• Predicted residual astigmatism less than 0.5D

Exclusion criteria

• Irregular corneal astigmatism or keratoconus
• Fuchs endothelial dystrophy (stage 2)
• Expected postoperative best-corrected visual acuity worse than logMAR +0.3

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 2 patient groups

Toric intraocular lens

Experimental group

Description:

Bilateral Toric intraocular lens implantation in cataract surgery

Treatment:

Device: AcrySof Toric intraocular lens, model SN60TT

Monofocal intraocular lens

Other group

Description:

Bilateral Monofocal intraocular lens implantation in cataract surgery

Treatment:

Device: AcrySof Monofocal IOL, model SN60AT