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NCT00761488 Clinical Trial

Recommendations for Monitoring Clinical Experience Following Implantation of the AcrySof® Toric

Cataract Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00761488
Other study ID # HK-Toric-YIU-01
Secondary ID
Status Withdrawn
Phase Phase 4
First received September 25, 2008
Last updated May 8, 2015

Study information
Verified date January 2010
Source Alcon Research
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

To allow surgeons to obtain clinical experience on the postoperative uncorrected and best distance corrected visual acuities (UCVA and BDCVA) and corneal and refractive cylinder of the AcrySof Toric IOL.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- 40-80 years old; of any race and gender; diagnosed with bilateral cataracts; require cataract extraction followed by implantation of a posterior chamber IOL; patients have between 0.75 -2.5 D of astigmatism preoperatively as measured by K readings.

Exclusion Criteria:

- Females of child bearing potential;irregular corneal astigmatism;keratopathy/Keratectasia; cornea inflammation or edema;previous corneal reshaping,dystrophy or transplant;amblyopia;glaucoma;RPE/Macular changes;diabetic retinopathy.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• AcrySof® Toric IOL
Implanted into the study eye

Locations
Country Name City State
United States Alcon Call Center Fort Worth Texas

Sponsors (1)
Lead Sponsor Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Corneal astigmatism; IOL rotation Before opertation; 1 day following implantation of each eye; 1, 3 months following lens implantation in the second eye. Yes
Secondary Uncorrected and best distance corrected visual acuities (UCVA and BDCVA) Before opertation; 1 day following implantation of each eye; 1, 3 months following lens implantation in the second eye. Yes
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