Efficacy and Cost-effectiveness of Toric Intraocular Lenses in Correcting Astigmatism in Cataract Surgery: a Randomised Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Astigmatism
- Sponsor
- Maastricht University Medical Center
- Enrollment
- 86
- Locations
- 3
- Primary Endpoint
- Spectacle independency
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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).
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Spectacle independency
Time Frame: preop, 3 months and 6 months postop
Spectacle independency for distance vision
Secondary Outcomes
- Costs related to intervention(preop, 3 and 6 months postop)
- 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)