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Acrysof Toric SN60T3corneal Astigmatism Between 0.75 and 1.00 D.

NCT00542581 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2018-07-24

No results posted yet for this study

Summary

The purpose of this study is to evaluate the visual outcomes and patient satisfaction after implantation of a toric IOL in patients with predicted residual corneal astigmatism between 0.75 and 1.00 D.

Cataract is prevalent throughout the world and IOLs are routinely implanted after the extraction of the cataractous lens. It is the most frequently performed surgery in the United States with an estimated 2-3 million procedures performed annually. With the aging population on the rise, as well as the increasing popularity of refractive intraocular lenses, the number of intraocular surgeries continues to rise. Over the years, the surgical technique has evolved from intracapsular extraction to modern phacoemulsification. This development has helped with the evolution of IOLs as well. The IOLs have advanced extensively: different materials and designs are available, permitting implantation through smaller, sutureless incisions. Traditional IOLs are of monofocal design providing vision at one distance, typically far; and correct mainly the spherical component of the refractive error. However, there are patients with corneal astigmatism that require additional surgical treatment such as laser correction (laser in situ leratomileusis, LASIK; photorefractive keratectomy, PRK) or limbal relaxing incisions, RLI). Another alternative is the use of a toric IOL, which has been especially designed to correct both the sphere and the astigmatism. The ACRYSOF Toric IOL is intended for primary implantation in the capsular bag of the eye for visual correction of aphakia and preexisting comeal astigmatism in adult patients with or without presbyopia, who desire improved uncorrected distance vision, reduction of residual refractive cylinder and increased spectacle independence for distance vision.

The treatment selection of the corneal astigmatism depends on the amount of cylinder as follows, between 0.25 and 0.75 D creating the surgical incision on the steep axis; between 0.75 and 1.75 D, RLI; between 1 and 2.25 D, toric IOLs; and between 1 and 3.00 D, LASIK/PRK.

Conditions

  • Cataracts

Interventions

DEVICE

The Acrysof toric SN60T3 IOL

Intraocular Lens

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Kerry D. Solomon, MD · Storm Eye Institute

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00542581 on ClinicalTrials.gov