Acrysof Toric SN60T3corneal Astigmatism Between 0.75 and 1.00 D.

NCT00542581 | Completed

• 1 other identifier: SEI 07-001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Visual Outcomes; Patient Satisfaction; Ophthalmology; Cataractous Lens

Outcome Measures

Primary Outcomes (1)

• The primary benefit from implantation of an IOL and participation in this study is the restoration of useful vision following removal of the cataracts.

  6 months

Study Arms (1)

The Acrysof toric SN60T3 IOL

EXPERIMENTAL

Multifocal Intraocular Lens

Device: The Acrysof toric SN60T3 IOL

Interventions

The Acrysof toric SN60T3 IOL DEVICE

Intraocular Lens

The Acrysof toric SN60T3 IOL

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects MUST fulfill the following conditions to qualify for enrollment into the trial
• Subject must have an age-related cataract in both eyes.
• years of age or older.
• Patient must desire cataract extraction.
• Expected maximum of 2 weeks and minimum of 1-week interval between first and second eye surgeries.
• Cross-cylinder value calculation from the Toric Calculator indicates a cross-cylinder correction from 0.75D to 1.0D in at least one eye and up to 1.75 in the fellow eye.
• Willing and able to comply with scheduled visits and other study procedures.

You may not qualify if:

• Subjects with ANY of the following conditions on the eligibility exam may NOT be enrolled into the trial.
• Preoperative ocular pathology:
• Amblyopia
• Rubella cataract
• Proliferative diabetic retinopathy
• Shallow anterior chamber
• Macular edema
• Retinal detachment
• Aniridia or iris atrophy
• Uveitis
• History of iritis
• Iris neovascularization
• Medically uncontrolled glaucoma
• Microphthalmus or macrophthalmus
• Optic nerve atrophy

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical Unvirsity of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Cataract; Patient Satisfaction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Kerry D. Solomon, MD

  Storm Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2007
• First Posted: October 11, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: July 24, 2018

Record last verified: 2010-10

Locations

US (1)