Trial Outcomes & Findings for Visual Function With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1 (NCT NCT00710931)

Results Overview

Uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m), 60 centimeters (cm), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

35 participants

Primary outcome timeframe

6 months after surgery

Results posted on

2011-12-12

Participant Flow

Participant milestones

Participant milestones
Measure	ReSTOR +3 Multifocal Lens Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
Overall Study STARTED	34
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Visual Function With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ReSTOR +3 Multifocal Lens n=34 Participants Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
Age Continuous	74.5 years STANDARD_DEVIATION 6.44 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months after surgery

Uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m), 60 centimeters (cm), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.

Outcome measures

Outcome measures
Measure	ReSTOR +3 Multifocal Lens n=34 Participants Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
Binocular Visual Acuity at Distance, Near and Intermediate Best Corrected VA at 4 m	0.00 LogMAR Standard Deviation 0.06
Binocular Visual Acuity at Distance, Near and Intermediate Best Corrected VA at 60 cm	0.09 LogMAR Standard Deviation 0.11
Binocular Visual Acuity at Distance, Near and Intermediate Best Corrected VA best near (41.31 cm +/- 5.82 cm)	0.07 LogMAR Standard Deviation 0.08
Binocular Visual Acuity at Distance, Near and Intermediate Uncorrected VA at 4 m	0.00 LogMAR Standard Deviation 0.08
Binocular Visual Acuity at Distance, Near and Intermediate Uncorrected VA at 60 cm	0.13 LogMAR Standard Deviation 0.11
Binocular Visual Acuity at Distance, Near and Intermediate Uncorrected VA best near (39.69 cm +/- 4.09 cm)	0.07 LogMAR Standard Deviation 0.08

Adverse Events

ReSTOR +3 Multifocal Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Alcon Clinical

Alcon Research, Ltd.

Phone: 888.451.3937; 817.568.6725

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee When a clinical study report or manuscript, in lieu of a final report, is completed, Alcon will provide the summary findings of the study to the investigator.
Publication restrictions are in place

Restriction type: OTHER