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Astigmatism Management in Cataract Surgery With the AcrySof Toric Intraocular Lens

This study has been completed.
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01075542
First received: February 24, 2010
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Astigmatism
 Device: AcrySof Toric intraocular lens, model SN60TT
Device: AcrySof Monofocal IOL, model SN60AT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Cost-effectiveness of Toric Intraocular Lenses in Correcting Astigmatism in Cataract Surgery: a Randomised Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Quality of vision [ Time Frame: preop, 3 months and 6 months postop ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual acuity [ Time Frame: preop, 1 day, 1 month, 3 months and 6 months postop ] [ Designated as safety issue: Yes ]
  • Frequency of spectacle wear [ Time Frame: preop, 3 months and 6 months postop ] [ Designated as safety issue: No ]
  • Higher-order wavefront aberrations [ Time Frame: preop, 3 months and 6 months postop ] [ Designated as safety issue: No ]
  • Contrast sensitivity [ Time Frame: preop, 3 months and 6 months postop ] [ Designated as safety issue: No ]
  • Costs related to intervention [ Time Frame: preop, 3 and 6 months postop ] [ Designated as safety issue: No ]
    Total cost-analysis, including out-of-hospital costs for patient


Enrollment: 86
Study Start Date: February 2010
Study Completion Date: November 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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 the quality of vision following toric IOL implantation and monofocal intraocular lens (IOL) implantation. The secondary objectives are to compare uncorrected distance vision, spectacle dependence, residual refractive astigmatism, 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).

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01075542

Locations
Netherlands
Atrium Medical Center
Heerlen, Brunssum, Kerkrade, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands, 6229 HX
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Rudy Nuijts, MD, PhD Maastricht University Medical Centre
  More Information

Publications:

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01075542     History of Changes
Other Study ID Numbers: 082099
Study First Received: February 24, 2010
Last Updated: December 5, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Corneal astigmatism
Intraocular lens

Additional relevant MeSH terms:
Astigmatism
Cataract
Refractive Errors
Eye Diseases
Lens Diseases

ClinicalTrials.gov processed this record on June 18, 2013