Clinical Trial: Astigmatism Management in Cataract Surgery With the AcrySof Toric Intraocular Lens

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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).


Sponsor: Maastricht University Medical Center

Current Primary Outcome: Spectacle independency [ Time Frame: preop, 3 months and 6 months postop ]

Spectacle independency for distance vision


Original Primary Outcome: Quality of vision [ Time Frame: preop, 3 months and 6 months postop ]

Current Secondary Outcome:

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


Original Secondary Outcome:

  • Visual acuity [ Time Frame: preop, 1 day, 1 month, 3 months and 6 months postop ]
  • Frequency of spectacle wear [ Time Frame: preop, 3 months and 6 months postop ]
  • Higher-order wavefront aberrations [ Time Frame: preop, 3 months and 6 months postop ]
  • Contrast sensitivity [ Time Frame: preop, 3 months and 6 months postop ]
  • Costs related to intervention [ Time Frame: preop, 3 and 6 months postop ]
    Total cost-analysis, including out-of-hospital costs for patient


Information By: Maastricht University Medical Center

Dates:
Date Received: February 24, 2010
Date Started: February 2010
Date Completion:
Last Updated: January 13, 2014
Last Verified: January 2014