Trial Outcomes & Findings for Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3 (NCT NCT00710905)

Results Overview

Binocular uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m) (distance), 60 centimeters (cm) (intermediate), 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. Scores were calculated using logMAR values. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

6 months after surgery

Results posted on

2011-11-24

Participant Flow

Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens (IOL). Subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal IOL and be willing and able to complete all follow-up visits.

Participant milestones

Participant milestones
Measure	ReSTOR Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
Overall Study STARTED	50
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ReSTOR n=50 Participants Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants
Gender Female	24 participants n=5 Participants
Gender Male	25 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months after surgery

Binocular uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m) (distance), 60 centimeters (cm) (intermediate), 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. Scores were calculated using logMAR values. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.

Outcome measures

Outcome measures
Measure	ReSTOR n=34 Participants Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
Binocular Visual Acuity at Near, Intermediate and Distance Uncorrected distance VA (4 m)	0.02 LogMAR Standard Deviation 0.08
Binocular Visual Acuity at Near, Intermediate and Distance Uncorrected intermediate VA (60 cm)	0.31 LogMAR Standard Deviation 0.11
Binocular Visual Acuity at Near, Intermediate and Distance Uncorrected best near VA (34.11 cm +/- 4.23 cm)	-0.02 LogMAR Standard Deviation 0.10
Binocular Visual Acuity at Near, Intermediate and Distance Best corrected distance VA (4 m)	-0.04 LogMAR Standard Deviation 0.07
Binocular Visual Acuity at Near, Intermediate and Distance Best corrected intermediate VA (60 cm)	0.31 LogMAR Standard Deviation 0.15
Binocular Visual Acuity at Near, Intermediate and Distance Best corrected best near VA (34.17 cm +/- 4.40 cm)	-0.01 LogMAR Standard Deviation 0.10

Adverse Events

ReSTOR

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ReSTOR n=50 participants at risk Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
Eye disorders Retinal Detachment	2.0% 1/50 • Number of events 1 • Surgical visit until 6 months after surgery.

Other adverse events

Other adverse events
Measure	ReSTOR n=50 participants at risk Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
Eye disorders Posterior Capsule Opacification	8.0% 4/50 • Number of events 5 • Surgical visit until 6 months after surgery.
Eye disorders Visual disturbances	4.0% 2/50 • Number of events 2 • Surgical visit until 6 months after surgery.
Eye disorders Allergic Reaction	2.0% 1/50 • Number of events 1 • Surgical visit until 6 months after surgery.
Eye disorders Redness	2.0% 1/50 • Number of events 1 • Surgical visit until 6 months after surgery.

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