Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3

Cataract Clinical Trial

Official title:

Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719732
• Other study ID #: M07-001
• Status: Completed
• Phase: Phase 4
• First received: July 21, 2008
• Last updated: March 4, 2010
• Start date: September 2007
• Est. completion date: May 2009

Study information

• Verified date: March 2010
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

A prospective evaluation of the visual parameters in a series of patients bilaterally implanted with AcrySof ReSTOR +3 Intraocular Lens (IOL).

Other known NCT identifiers

• NCT00762203

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Diagnosed with cataracts

Exclusion Criteria:

• Pre-existing conditions that could skew the results or are contraindications for the ReSTOR intraocular lens;

• <1 diopter astigmatism by keratometry readings.

Study Design

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• ReSTOR
Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).

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 Visual Acuity (UCVA)	Uncorrected Visual Acuity (UCVA) measured by means of logMAR at various distances (40 centimeters (cm), 50 cm, 60 cm, 70 cm, and 4 meters (m)). 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