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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
86
The lens is made of foldable acrylic material and is implanted in the capsular bag
The lens is made of foldable acrylic material and is implanted in the capsular bag
Atrium Medical Center
Heerlen, Brunssum, Kerkrade, Netherlands
Maastricht University Medical Center
Maastricht, Netherlands
Rotterdam Eye Hospital
Rotterdam, Netherlands
Spectacle independency
Spectacle independency for distance vision
Time frame: preop, 3 months and 6 months postop
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
Total cost-analysis, including out-of-hospital costs for patient
Time frame: preop, 3 and 6 months postop
Quality of vision
Refractive-error related quality of vision
Time frame: preop, 3 months, 6 months
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