Astigmatism Management in Cataract Surgery With the AcrySof Toric Intraocular Lens

Not Applicable

Completed

• Conditions: Astigmatism
• Interventions: Device: AcrySof Toric intraocular lens, model SN60TT; Device: AcrySof Monofocal IOL, model SN60AT

• Registration Number: NCT01075542
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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

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).

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-24
• Study First Submitted QC: 2010-02-24
• Study First Posted: 2010-02-25
• Primary Completion: 2012-10
• Study Completion: 2012-11
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-13
• Last Update Posted: 2014-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Toric intraocular lens	AcrySof Toric intraocular lens, model SN60TT	Bilateral Toric intraocular lens implantation in cataract surgery
Monofocal intraocular lens	AcrySof Monofocal IOL, model SN60AT	Bilateral Monofocal intraocular lens implantation in cataract surgery

Primary Outcome Measures

Name	Time	Method
Spectacle independency	preop, 3 months and 6 months postop	Spectacle independency for distance vision

Secondary Outcome Measures

Name	Time	Method
Costs related to intervention	preop, 3 and 6 months postop	Total cost-analysis, including out-of-hospital costs for patient
Visual acuity	preop, 1 day, 1 month, 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
Refractive astigmatism	preop, 3 months and 6 months postop
Quality of vision	preop, 3 months, 6 months	Refractive-error related quality of vision

Trial Locations

Locations (3)

Atrium Medical Center; 🇳🇱 Heerlen, Brunssum, Kerkrade, Netherlands

Maastricht University Medical Center; 🇳🇱 Maastricht, Netherlands

Rotterdam Eye Hospital; 🇳🇱 Rotterdam, Netherlands