Astigmatism Management in Cataract Surgery With the AcrySof Toric Intraocular Lens
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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
|
| Other: 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
Primary Outcome Measures
- Spectacle independency [preop, 3 months and 6 months postop]
Spectacle independency for distance vision
Secondary Outcome Measures
- Visual acuity [preop, 1 day, 1 month, 3 months and 6 months postop]
- Refractive astigmatism [preop, 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]
- Costs related to intervention [preop, 3 and 6 months postop]
Total cost-analysis, including out-of-hospital costs for patient
- Quality of vision [preop, 3 months, 6 months]
Refractive-error related quality of vision
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Bilateral cataract
-
Bilateral corneal astigmatism (at least 1.25D)
-
Predicted residual astigmatism less than 0.5D
Exclusion Criteria:
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Irregular corneal astigmatism or keratoconus
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Fuchs endothelial dystrophy (stage 2)
-
Expected postoperative best-corrected visual acuity worse than logMAR +0.3
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Atrium Medical Center | Heerlen, Brunssum, Kerkrade | Netherlands | ||
| 2 | Maastricht University Medical Center | Maastricht | Netherlands | 6229 HX | |
| 3 | Rotterdam Eye Hospital | Rotterdam | Netherlands |
Sponsors and Collaborators
- Maastricht University Medical Center
- ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
- Principal Investigator: Rudy Nuijts, MD, PhD, Maastricht University Medical Centre
Study Documents (Full-Text)
None provided.More Information
Publications
- 082099