Visual Function After Bilateral Implantation of AcrySof® Toric

Visual Function Clinical Trial

Official title:

Visual Function After Bilateral Implantation of AcrySof® Toric

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00758550
• Other study ID #: CM-06-17
• Status: Completed
• Phase: Phase 4
• First received: September 23, 2008
• Last updated: March 4, 2010
• Start date: April 2007

Study information

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

Clinical Trial Summary

The objective of this study was to evaluate visual function of AcrySof Toric and AcrySof Natural Intraocular Lenses (IOLs) following implant for replacement of cataract.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Bilateral cataracts

• 40~80 years of age

• 4 Days - 1 Week interval between a single patient's surgery

• dilated pupil size (in dim light) = 4.0 mm

• Anticipated correction with an IOL of +10 Diopters ~ +25 Diopters

• 0.75 - 2.0 Diopters of astigmatism preoperatively as measured by Keratometry readings

Exclusion Criteria:

• Preoperative ocular pathology

• Previous intraocular or corneal surgery

• An increased risk for complications which could require vitreoretinal surgery

• Corneal irregularities

• Corneal opacities

• Current contact lens usage(within 6 months prior to first surgery)

Study Design

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

Related Conditions & MeSH terms

• Visual Function

Intervention

Device:
• AcrySof® Toric IOL
AcrySof® Toric Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery
• AcrySof Natural
AcrySof Natural Intraocular Lens (IOL) implanted into the study eye following cataract extraction surgery

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	Uncorrected Visual Acuity (UCVA)	Uncorrected Visual Acuity (UCVA) from surgery measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.	6 Months after surgery	Yes
Secondary	Questionnaire Results	Results of questionnaire rating the quality of distance vision without glasses or contact lenses. Measured on a scale of 0 to 6 (0 = worst, 6 = best).	6 Months	No