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Astigmatism Management in Cataract Surgery With the AcrySof Toric Intraocular Lens

2014-08-27 03:15:37 | BioPortfolio

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.

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 the quality of vision following toric IOL implantation and monofocal intraocular lens (IOL) implantation. The secondary objectives are to compare uncorrected distance vision, spectacle dependence, residual refractive astigmatism, 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Astigmatism

Intervention

AcrySof Toric intraocular lens, model SN60TT, AcrySof Monofocal IOL, model SN60AT

Location

Atrium Medical Center
Heerlen, Brunssum, Kerkrade
Netherlands
6229 HX

Status

Recruiting

Source

Maastricht University Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:37-0400

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Medical and Biotech [MESH] Definitions

Insertion of an artificial lens to replace the natural CRYSTALLINE LENS after CATARACT EXTRACTION or to supplement the natural lens which is left in place.

Lenses, generally made of plastic or silicone, that are implanted into the eye in front of the natural EYE LENS, by the IRIS, to improve VISION, OCULAR. These intraocular lenses are used to supplement the natural lens instead of replacing it.

Presence of an intraocular lens after cataract extraction.

Statistical formulations or analyses which, when applied to data and found to fit the data, are then used to verify the assumptions and parameters used in the analysis. Examples of statistical models are the linear model, binomial model, polynomial model, two-parameter model, etc.

The portion of the crystalline lens surrounding the nucleus and bound anteriorly by the epithelium and posteriorly by the capsule. It contains lens fibers and amorphous, intercellular substance.

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