Astigmatism Management in Cataract Surgery With the AcrySof Toric Intraocular Lens

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-11-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Astigmatism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Toric intraocular lens

Bilateral Toric intraocular lens implantation in cataract surgery

Group Type EXPERIMENTAL

AcrySof Toric intraocular lens, model SN60TT

Intervention Type DEVICE

The lens is made of foldable acrylic material and is implanted in the capsular bag

Monofocal intraocular lens

Bilateral Monofocal intraocular lens implantation in cataract surgery

Group Type OTHER

AcrySof Monofocal IOL, model SN60AT

Intervention Type DEVICE

The lens is made of foldable acrylic material and is implanted in the capsular bag

Interventions

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AcrySof Toric intraocular lens, model SN60TT

The lens is made of foldable acrylic material and is implanted in the capsular bag

Intervention Type DEVICE

AcrySof Monofocal IOL, model SN60AT

The lens is made of foldable acrylic material and is implanted in the capsular bag

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No