Visual Function Evaluation of Bilateral AcrySof ReSTOR Aspheric IOL

Cataracts Clinical Trial

Official title:

Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric Intraocular Lens (IOL): Postmarket Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00818116
• Other study ID #: CH-08-001
• Status: Completed
• Phase: Phase 4
• First received: January 6, 2009
• Last updated: June 30, 2010
• Start date: December 2008

Study information

• Verified date: June 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 is to evaluate postoperative visual function in patients implanted bilaterally with the ReSTOR Aspheric Intraocular Lens (IOL).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Bilateral cataract patients who require natural crystalline lens removal and bilateral Intraocular Lens (IOL) implantation.

• 50~75 years of age

• <1 Diopter of astigmatism preoperatively (before surgery) as measured by Keratometry readings.

Exclusion Criteria:

• Patients with pre-existing conditions that could skew the results.

• Any of conditions before and during surgery specified in the product information.

Study Design

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

Related Conditions & MeSH terms

• Cataract
• Cataracts

Intervention

Device:
• AcrySof ReSTOR Aspheric IOL
Bilateral implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL) for the replacement of cataract in the natural lens of the eye.

Locations

Country	Name	City	State
United States	Alcon Call Center for Trial Locations	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 and Best Corrected Visual Acuities (Near and Distance)	Measurement of uncorrected (without spectacles or other visual corrective devices) and best-corrected (with spectacles or other visual corrective devices)visual acuity at both near and distance. Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.	6 Months Following Cataract Surgery	No