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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toric intraocular lens | Experimental | Bilateral Toric intraocular lens implantation in cataract surgery |
|
| Monofocal intraocular lens | Other | Bilateral Monofocal intraocular lens implantation in cataract surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcrySof Toric intraocular lens, model SN60TT | Device | The lens is made of foldable acrylic material and is implanted in the capsular bag |
|
| Measure | Description | Time Frame |
|---|---|---|
| Spectacle independency | Spectacle independency for distance vision | preop, 3 months and 6 months postop |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rudy Nuijts, MD, PhD | Maastricht University Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Medical Center | Heerlen, Brunssum, Kerkrade | Netherlands | ||||
| Maastricht University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18721707 | Background | Bauer NJ, de Vries NE, Webers CA, Hendrikse F, Nuijts RM. Astigmatism management in cataract surgery with the AcrySof toric intraocular lens. J Cataract Refract Surg. 2008 Sep;34(9):1483-8. doi: 10.1016/j.jcrs.2008.05.031. | |
| 25256624 | Derived | Visser N, Beckers HJ, Bauer NJ, Gast ST, Zijlmans BL, Berenschot TT, Webers CA, Nuijts RM. Toric vs aspherical control intraocular lenses in patients with cataract and corneal astigmatism: a randomized clinical trial. JAMA Ophthalmol. 2014 Dec;132(12):1462-8. doi: 10.1001/jamaophthalmol.2014.3602. |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| AcrySof Monofocal IOL, model SN60AT | Device | The lens is made of foldable acrylic material and is implanted in the capsular bag |
|
| preop, 3 months and 6 months postop |
| Contrast sensitivity | preop, 3 months and 6 months postop |
| Costs related to intervention | Total cost-analysis, including out-of-hospital costs for patient | preop, 3 and 6 months postop |
| Quality of vision | Refractive-error related quality of vision | preop, 3 months, 6 months |
| Maastricht |
| 6229 HX |
| Netherlands |
| Rotterdam Eye Hospital | Rotterdam | Netherlands |