Trial Outcomes & Findings for Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric IOL (NCT NCT00934622)

Results Overview

Comparison of visual acuity (measured in logMAR) prior to and following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL). Visual parameters were assessed prior to and after the implantation of the second lens at 1 week, 1 month, 3 months, and 6 months. LogMAR, the unit of measure for visual acuity, 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

76 participants

Primary outcome timeframe

pre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery

Results posted on

2010-05-06

Participant Flow

Subjects \>21 years of age, either sex, and any race. Diagnosis of cataracts in both eyes. 27-Jun-2007 to 20-May-2009

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

Participant milestones

Participant milestones
Measure	AcrySof® ReSTOR® Aspheric IOL AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
Overall Study STARTED	76
Overall Study COMPLETED	68
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	AcrySof® ReSTOR® Aspheric IOL AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
Overall Study Lost to Follow-up	7
Overall Study 2nd Intraoperative exclusion criteria	1

Baseline Characteristics

Visual Function After Implantation of Bilateral AcrySoft ReSTOR Aspheric IOL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AcrySof® ReSTOR® Aspheric IOL n=76 Participants AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants
Age, Categorical >=65 years	43 Participants n=5 Participants
Gender Female	48 participants n=5 Participants
Gender Male	27 participants n=5 Participants

PRIMARY outcome

Timeframe: pre-operative;1 week,1 month, 3 months and 6 months after 2nd eye surgery

Comparison of visual acuity (measured in logMAR) prior to and following bilateral implantation of the AcrySof ReSTOR Aspheric Intraocular Lens (IOL). Visual parameters were assessed prior to and after the implantation of the second lens at 1 week, 1 month, 3 months, and 6 months. LogMAR, the unit of measure for visual acuity, is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.

Outcome measures

Outcome measures
Measure	AcrySof® ReSTOR® Aspheric IOL n=76 Participants AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
Visual Acuity Preoperative	0.54 logMAR Standard Deviation 0.3
Visual Acuity 1 Week	0.06 logMAR Standard Deviation 0.12
Visual Acuity 1 Month	0.03 logMAR Standard Deviation 0.08
Visual Acuity 3 Months	0.04 logMAR Standard Deviation 0.08
Visual Acuity 6 Months	0.05 logMAR Standard Deviation 0.09

SECONDARY outcome

Timeframe: pre-op;1 week,1 month,3 months and 6 months after 2nd eye surgery

Population: Patient population was not consistent throughout the study. Number of patients analyzed at each visit is as follows: Preoperative n=76, Week 1 n=61, 1 Month n=71, 3 Months n=70, 6 Months n=68.

Spectacle independence is the percentage of patients that do not always need to wear glasses. This outcome measure is patient reported.

Outcome measures

Outcome measures
Measure	AcrySof® ReSTOR® Aspheric IOL n=76 Participants AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
Spectacle Independence 1 Week Postoperative	96.8 Percentage of Participants
Spectacle Independence 1 Month Postoperative	97.2 Percentage of Participants
Spectacle Independence 3 Months Postoperative	98.6 Percentage of Participants
Spectacle Independence Preoperative	29 Percentage of Participants
Spectacle Independence 6 Months Postoperative	100 Percentage of Participants

Adverse Events

AcrySof® ReSTOR® Aspheric IOL

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

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

Restriction type: LTE60