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Astigmatism Management in Cataract Surgery With the AcrySof Toric Intraocular Lens

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ClinicalTrials.gov Identifier: NCT01075542
Recruitment Status : Completed
First Posted : February 25, 2010
Last Update Posted : January 14, 2014
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by (Responsible Party):
Maastricht University Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Astigmatism Device: AcrySof Toric intraocular lens, model SN60TT Device: AcrySof Monofocal IOL, model SN60AT Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Cost-effectiveness of Toric Intraocular Lenses in Correcting Astigmatism in Cataract Surgery: a Randomised Clinical Trial
Study Start Date : February 2010
Actual Primary Completion Date : October 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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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
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


Outcome Measures
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Primary Outcome Measures :
  1. Spectacle independency [ Time Frame: preop, 3 months and 6 months postop ]
    Spectacle independency for distance vision


Secondary Outcome Measures :
  1. Visual acuity [ Time Frame: preop, 1 day, 1 month, 3 months and 6 months postop ]
  2. Refractive astigmatism [ Time Frame: preop, 3 months and 6 months postop ]
  3. Higher-order wavefront aberrations [ Time Frame: preop, 3 months and 6 months postop ]
  4. Contrast sensitivity [ Time Frame: preop, 3 months and 6 months postop ]
  5. Costs related to intervention [ Time Frame: preop, 3 and 6 months postop ]
    Total cost-analysis, including out-of-hospital costs for patient

  6. Quality of vision [ Time Frame: preop, 3 months, 6 months ]
    Refractive-error related quality of vision


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075542


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01075542    
Other Study ID Numbers: 082099
First Posted: February 25, 2010    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014
Keywords provided by Maastricht University Medical Center:
Corneal astigmatism
Intraocular lens
Additional relevant MeSH terms:
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Cataract
Astigmatism
Lens Diseases
Eye Diseases
Refractive Errors