NCT00759096

Brief Summary

The purpose of this study is to assess uniocular and binocular unaided distance, intermediate, and near VA; contrast sensitivity, accommodation amplitude, stereopsis, glare testing, ocular aberrations and the clinical satisfaction assessment after bilateral implant of the Restor IOL.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

February 10, 2010

Completed
Last Updated

December 5, 2023

Status Verified

January 1, 2010

Enrollment Period

1.2 years

First QC Date

September 23, 2008

Results QC Date

September 11, 2009

Last Update Submit

November 13, 2023

Conditions

Visual Acuity

Keywords

bilateral implantationReSTOR Aspheric IOLuniocular unaided distancebinocular unaided distanceintermediate visual acuitynear visual acuity

Outcome Measures

Primary Outcomes (1)

  • Near Uncorrected Visual Acuity(UCVA

    Near uncorrected visual acuity(UCVA) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution and is used to measure visual acuity.

    6 months after surgery of 2nd eye

Secondary Outcomes (1)

  • Contrast Sensitivity

    6 months after sugery of the 2nd eye

Study Arms (1)

Acrysof ReSTOR IOL

EXPERIMENTAL

AcrySof ReSTOR Intraocular lens (IOL) implanted

Device: RESTOR IOL Model SA60D3

Interventions

RESTOR IOL Model SA60D3DEVICE

Implanted into the study eye following cataract extraction surgery

Acrysof ReSTOR IOL

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥21 years of either gender or any race
  • Potential post-op VA 20/20
  • Pre-op astigmatism ≤ 1.0D
  • Able to sign the informed consent
  • Able to complete all required postoperative visits
  • Planned cataract removal by phaco
  • Clear intraocular media other than cataract

You may not qualify if:

  • Signs of capsular tear, significant anterior chamber hyphema, or zonular rupture
  • Any corneal pathology and previous corneal refractive surgery
  • Patients with unrealistic expectations in anticipated post-op VA
  • Happy to wear glasses
  • Occupational night driver

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcon Call Center

Fort Worth, Texas, 76134, United States

Location

Results Point of Contact

Title
Benny Li, PhD
Organization
Alcon Research, Ltd.
Benny.Li@Alconlabs.com
+86 21 6375 8762

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2008

First Posted

September 25, 2008

Study Start

May 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

December 5, 2023

Results First Posted

February 10, 2010

Record last verified: 2010-01

Locations

US(1)