Astigmatism
Conditions
Keywords
Corneal astigmatism, Intraocular lens
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).
Interventions
DEVICEAcrySof Toric intraocular lens, model SN60TT
The lens is made of foldable acrylic material and is implanted in the capsular bag
DEVICEAcrySof Monofocal IOL, model SN60AT
The lens is made of foldable acrylic material and is implanted in the capsular bag
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spectacle independency | preop, 3 months and 6 months postop | Spectacle independency for distance vision |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity | preop, 1 day, 1 month, 3 months and 6 months postop | — |
| Refractive astigmatism | preop, 3 months and 6 months postop | — |
| Quality of vision | preop, 3 months, 6 months | Refractive-error related quality of vision |
| Contrast sensitivity | preop, 3 months and 6 months postop | — |
| Costs related to intervention | preop, 3 and 6 months postop | Total cost-analysis, including out-of-hospital costs for patient |
| Higher-order wavefront aberrations | preop, 3 months and 6 months postop | — |
Countries
Netherlands
Outcome results
None listed