Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

Visual Outcomes Clinical Trial

Official title:

A Six-months, Open-labelled Clinical Assessment of Visual Function After Bilateral Implantation of Arcysof ReSTOR Multifocal Intra-ocular Lens

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00758940
• Other study ID #: HK-Restor-YIU-01
• Status: Withdrawn
• Phase: Phase 4
• First received: September 23, 2008
• Last updated: May 8, 2015

Study information

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

Clinical Trial Summary

An unmasked trial after bilateral implantation of AcrySof® ReSTOR®, SA60D3 IOL . Enrolled are at least 30 patients or as much as possible from the doctor's clinical practice perspective. 6 months follow-up after IOL implant in the 2nd eye

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Able to complete all required postoperative visits; Planned cataract removal by phaco; 21 years of age or older, either gender or any race; potential postoperative visual acuity of 20/20; astigmatism ?1.0D measured by keratometry in study eye(s);clear int

Exclusion Criteria:

• Signs of capsular tear, significant anterior chamber hyphema;zonular rupture; corneal pathology and refractive surgery;hypercritical patient; patients with unrealistic expectations in post-op VA; happy to wear glasses;occupational night drivers

Study Design

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

Related Conditions & MeSH terms

• Visual Outcomes

Intervention

Device:
• Acrysof ReSTOR multifocal 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	Near,intermediate,distance visual acuity		pre-op;1 week after 1st eye surgery,1month and 6 month after 2nd eye surgery	Yes
Secondary	contrast sensitivity		6 month after 2nd eye surgery	Yes