Trial Outcomes & Findings for Visual Function Evaluation of Bilateral AcrySof ReSTOR Aspheric IOL (NCT NCT00818116)

Results Overview

Measurement of uncorrected (without spectacles or other visual corrective devices) and best-corrected (with spectacles or other visual corrective devices)visual acuity at both near and distance. 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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

34 participants

Primary outcome timeframe

6 Months Following Cataract Surgery

Results posted on

2010-07-30

Participant Flow

34 eligible patients were enrolled into the study

Open-label, single arm, non-randomized

Participant milestones

Participant milestones
Measure	ReSTOR Aspheric Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
Overall Study STARTED	34
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Visual Function Evaluation of Bilateral AcrySof ReSTOR Aspheric IOL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ReSTOR Aspheric n=34 Participants Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	20 Participants n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months Following Cataract Surgery

Measurement of uncorrected (without spectacles or other visual corrective devices) and best-corrected (with spectacles or other visual corrective devices)visual acuity at both near and distance. 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.

Outcome measures

Outcome measures
Measure	ReSTOR Aspheric n=34 Participants Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
Uncorrected and Best Corrected Visual Acuities (Near and Distance) Near Uncorrected Visual Acuity	0.02 logMAR Standard Deviation 0.08
Uncorrected and Best Corrected Visual Acuities (Near and Distance) Near Best-Corrected Visual Acuity	0.01 logMAR Standard Deviation 0.07
Uncorrected and Best Corrected Visual Acuities (Near and Distance) Distance Uncorrected Visual Acuity	0.00 logMAR Standard Deviation 0.07
Uncorrected and Best Corrected Visual Acuities (Near and Distance) Distance Best-Corrected Visual Acuity	-0.03 logMAR Standard Deviation 0.07

Adverse Events

ReSTOR Aspheric

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ReSTOR Aspheric n=34 participants at risk Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
Eye disorders Glare	2.9% 1/34 • Number of events 1 • 1 Day, 1 Month, 3 Months, and 6 Months following cataract surgery.

Additional Information

Alcon Clinical

Alcon Research, Ltd.

Phone: 888.451.3937; 817.568.6725

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place