Contralateral ReSTOR / Monofocal or Phakic Eye

Cataracts Clinical Trial

Official title:

Clinical Outcomes With AcrySof ReSTOR Aspheric Apodized Diffractive Intraocular Lens (IOL) in One Eye and a Contralateral Monofocal IOL or Phakic Eye

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00731640
• Other study ID #: M07-012
• Status: Completed
• Phase: Phase 4
• First received: August 7, 2008
• Last updated: March 19, 2010
• Start date: June 2007

Study information

• Verified date: March 2010
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Bilateral evaluation of unilateral implantation of ReSTOR and contralateral monofocal or phakic eye.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Unilateral operable cataract

• Candidate for presbyopic intraocular lens (IOL)

Exclusion Criteria:

• Ocular comorbidities compromising primary outcome

• Bilateral cataracts

Study Design

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

Related Conditions & MeSH terms

• Cataracts

Intervention

Device:
• ReSTOR
AcrySof ReSTOR +4 Intraocular Lens (IOL) unilaterally implanted

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	Visual Acuity	Uncorrected 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	No
Secondary	Contrast Sensitivity	Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic (log) units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.	6 Months	No
Secondary	Patient Satisfaction	Average rating of patient satisfaction based on a patient survey. The survey had a 10 point scale (10 being most satisfied and 0 being most unsatisfied).	6 Months Postoperative	No
Secondary	Spectacle Independence	The percentage of patients reporting spectacle independence (no longer needing to wear glasses).	6 Months	No