Visual Function After Implantation of Bilateral AcrySof® Toric Natural Intraocular Lens

January 12, 2012 updated by: Alcon Research
The purpose of this study is to evaluate the effect that placement and power of the AcrySof Toric has on post-operative visual acuity and spectacle independence for distance vision. This will be determined by comparing manifest refraction pre-operatively and post-operatively and by evaluating the rotational stability of the lens over time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76134
        • Alcon Call Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Are a candidate for bilateral implantation
  • In good general and ocular health, 21 years of age or older, of either gender or any race, diagnosed with age-related cataracts in both eyes
  • In need of spherical correction between 10.0 Diopter (D) and 30.0 D
  • Preoperative regular corneal astigmatism, ≥ 1.0 D and ≤ 2.5 D , as measured by keratometry
  • Willing and able to complete all required postoperative visits
  • Able to comprehend and sign a statement of informed consent
  • Pupil dilation ≥ 6.0 mm
  • Expected to achieve a postoperative logMAR +0.3 or better visual acuity (as assessed by one or more of the following: fundus examination, pinhole visual acuity, and/or PAM evaluation);

Exclusion Criteria:

Exclusion Criteria Before Surgery - Ocular

  • Previous cataract patient without potential of bilateral implantation
  • Females of child bearing potential
  • Irregular corneal astigmatism
  • Keratopathy/Keratectasia - any corneal abnormality including but not limited to the following: keratoconus, keratoglobus, keratolysis, keratomalacia, keratomycosis, and cornea plana
  • Any inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis
  • Previous corneal reshaping, including but not limited to the following: keratomileusis, radial keratotomy (RK), photorefractive keratectomy (PRK), Laser in Situ Keratomileusis (LASIK), Thermal Keratoplasty (TK), and Penetrating Keratoplasty (PK)
  • Clinically significant corneal dystrophy (including Fuch's dystrophy)
  • Previous corneal transplant
  • Amblyopia
  • Glaucoma (medically uncontrolled)
  • Clinically significant RPE/Macular changes
  • Proliferative diabetic retinopathy
  • History of macular edema
  • Previous history of retinal detachment
  • History of uveitis/iritis
  • Extremely shallow anterior chamber, not due to swollen cataract
  • Iris neovascularization
  • Microphthalmos
  • Absent eye or eye with no light perception (NLP) as fellow eye
  • Rubella, congenital, traumatic, or complicated cataract
  • Optic atrophy

Exclusion Criteria During Surgery

  • Other procedures at this surgery
  • Limbal relaxing incisions (LRIs) or any other procedure to reduce the amount of preoperative astigmatism on the study eye(s), whether implanted with SA60TT or SA60AT, for the duration of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AcrySof Toric IOL
AcrySof Toric Intraocular Lens (IOL)
Device: AcrySof Toric IOL
Implantation with the AcrySof Toric IOL for cataract replacement and multiple follow-up assessments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Acuity (VA)
Time Frame: Pre-operative, 1 month, 3 month, and 6 month post-operative
Pre-operative and 1 month, 3 month, and 6 month post-operative visual acuity (VA) measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).
Pre-operative, 1 month, 3 month, and 6 month post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spectacle Independence
Time Frame: 6 months post-operative
Percentage of subjects reporting that they never wear glasses at the 6 month post-operative visit
6 months post-operative
IOL Rotation
Time Frame: 6 months post-operative
Evaluation of percentage of patients that experienced rotation of the intraocular lens (IOL) less than or equal to 5 degrees from initial implantation, and less than or equal to 10 degrees from initial implantation.
6 months post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

September 25, 2008

First Submitted That Met QC Criteria

September 25, 2008

First Posted (Estimate)

September 26, 2008

Study Record Updates

Last Update Posted (Estimate)

January 16, 2012

Last Update Submitted That Met QC Criteria

January 12, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALCONsurtor001.06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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