Surgeon Experience ReSTOR A +4 Intraocular Lens (IOL)

Cataract Clinical Trial

Official title:

Surgeon Experience ReSTOR Aspheric +4 Intraocular Lens (IOL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733512
• Other study ID #: M07-019
• Status: Completed
• Phase: Phase 4
• First received: August 8, 2008
• Last updated: April 14, 2010
• Start date: June 2007

Study information

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

Clinical Trial Summary

To collect visual outcome data post AcrySof ReSTOR Aspheric +4 implantation from surgeons throughout the United States.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• operable cataracts; candidate for presbyopic correcting intraocular lens (IOL)

Exclusion Criteria:

• ocular comorbidities confounding study outcomes

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• ReSTOR
Patients were implanted with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL) in one or both eyes for treatment of cataract.

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 (UCVA) and Best Spectacle Corrected Visual Acuity (BSCVA) at distance (4 meters) and near at preferred distance and measured by logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity.	1 week to 10 months	No
Secondary	Contrast Sensitivity	Contrast sensitivity is the measurement of how faded an image may become before it is indistinguishable. Contrast sensitivity was measured in photopic, mesopic, and mesopic with glare conditions at the following spatial frequencies: 1.5, 3, 6, 12, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity.	1 week to 10 months	No