Trial Outcomes & Findings for Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3 (NCT NCT00719732)

Results Overview

Uncorrected Visual Acuity (UCVA) measured by means of logMAR at various distances (40 centimeters (cm), 50 cm, 60 cm, 70 cm, and 4 meters (m)). 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

218 participants

Primary outcome timeframe

6 months

Results posted on

2010-03-16

Participant Flow

Subjects 18 - 70 years of age, either sex and any race. Diagnosis of cataracts in one or both eyes.

Subject's eligibility was determined at the preoperative visit. All subjects met inclusion/exclusion criteria.

Participant milestones

Participant milestones
Measure	ReSTOR Aspheric +3 Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
Overall Study STARTED	218
Overall Study COMPLETED	196
Overall Study NOT COMPLETED	22

Reasons for withdrawal

Reasons for withdrawal
Measure	ReSTOR Aspheric +3 Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
Overall Study Lost to Follow-up	20
Overall Study Unilateral (not bilateral) implantation	1
Overall Study Illness not associated with device	1

Baseline Characteristics

Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ReSTOR Aspheric +3 n=218 Participants Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
Age Categorical <=18 years	0 participants n=5 Participants
Age Categorical Between 18 and 65 years	143 participants n=5 Participants
Age Categorical >=65 years	64 participants n=5 Participants
Gender Female	88 participants n=5 Participants
Gender Male	124 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Uncorrected Visual Acuity (UCVA) measured by means of logMAR at various distances (40 centimeters (cm), 50 cm, 60 cm, 70 cm, and 4 meters (m)). 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 +3 n=196 Participants Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
Uncorrected Visual Acuity (UCVA) UCVA at 40 cm	0.05 logMAR Standard Deviation 0.10
Uncorrected Visual Acuity (UCVA) UCVA at 50 cm	-0.07 logMAR Standard Deviation 0.15
Uncorrected Visual Acuity (UCVA) UCVA at 60 cm	0.15 logMAR Standard Deviation 0.14
Uncorrected Visual Acuity (UCVA) UCVA at 70 cm	0.20 logMAR Standard Deviation 0.13
Uncorrected Visual Acuity (UCVA) UCVA at 4 m	-0.01 logMAR Standard Deviation 0.11

Adverse Events

ReSTOR Aspheric +3

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ReSTOR Aspheric +3 n=196 participants at risk Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
Eye disorders Chronic inflammation/iritis	0.51% 1/196 • Number of events 1 • Up to 6 months post-operative Volunteered and solicited adverse events were collected from the time of surgery to the 6 month post-operative visit.

Other adverse events

Adverse event data not reported

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 No paper that incorporates Sponsor Condfidential information will be submitted for publication without Sponsor's prior written agreement.
Publication restrictions are in place

Restriction type: OTHER