Astigmatism Management in Cataract Surgery With the AcrySof Toric Intraocular Lens

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

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.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: AcrySof Toric intraocular lens, model SN60TT; Device: AcrySof Monofocal IOL, model SN60AT

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 Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Heerlen, Brunssum, Kerkrade, Netherlands
    • Atrium Medical Center
  • Maastricht, Netherlands, 6229 HX
    • Maastricht University Medical Center
  • Rotterdam, Netherlands
    • Rotterdam Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development
• Investigators: Principal Investigator: Rudy Nuijts, MD, PhD, Maastricht University Medical Centre

Publications and helpful links

General Publications

• Bauer NJ, de Vries NE, Webers CA, Hendrikse F, Nuijts RM. Astigmatism management in cataract surgery with the AcrySof toric intraocular lens. J Cataract Refract Surg. 2008 Sep;34(9):1483-8. doi: 10.1016/j.jcrs.2008.05.031.
• Visser N, Beckers HJ, Bauer NJ, Gast ST, Zijlmans BL, Berenschot TT, Webers CA, Nuijts RM. Toric vs aspherical control intraocular lenses in patients with cataract and corneal astigmatism: a randomized clinical trial. JAMA Ophthalmol. 2014 Dec;132(12):1462-8. doi: 10.1001/jamaophthalmol.2014.3602.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: February 24, 2010
• First Submitted That Met QC Criteria: February 24, 2010
• First Posted (Estimate): February 25, 2010

Study Record Updates

• Last Update Posted (Estimate): January 14, 2014
• Last Update Submitted That Met QC Criteria: January 13, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Corneal astigmatism; Intraocular lens
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Astigmatism
• Other Study ID Numbers: 082099