Astigmatism Management in Cataract Surgery With the AcrySof Toric Intraocular Lens

Study Overview
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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.

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).

Official Title
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Efficacy and Cost-effectiveness of Toric Intraocular Lenses in Correcting Astigmatism in Cataract Surgery: a Randomised Clinical Trial

Conditions
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Astigmatism

Intervention / Treatment
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* Device: AcrySof Toric intraocular lens, model SN60TT
* Device: AcrySof Monofocal IOL, model SN60AT


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Toric intraocular lens<br>Bilateral Toric intraocular lens implantation in cataract surgery | Device: AcrySof Toric intraocular lens, model SN60TT<br>* The lens is made of foldable acrylic material and is implanted in the capsular bag<br>|
| Other: Monofocal intraocular lens<br>Bilateral Monofocal intraocular lens implantation in cataract surgery | Device: AcrySof Monofocal IOL, model SN60AT<br>* The lens is made of foldable acrylic material and is implanted in the capsular bag<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spectacle independency | Spectacle independency for distance vision | preop, 3 months and 6 months postop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | preop, 1 day, 1 month, 3 months and 6 months postop | 
| Refractive astigmatism |  | preop, 3 months and 6 months postop | 
| Higher-order wavefront aberrations |  | preop, 3 months and 6 months postop | 
| Contrast sensitivity |  | preop, 3 months and 6 months postop | 
| Costs related to intervention | Total cost-analysis, including out-of-hospital costs for patient | preop, 3 and 6 months postop | 
| Quality of vision | Refractive-error related quality of vision | preop, 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Corneal astigmatism, Intraocular lens