Trial Outcomes & Findings for Surgeon Experience ReSTOR A +4 Intraocular Lens (IOL) (NCT NCT00733512)

Last Updated: 2017-03-27

Results Overview

Uncorrected Visual Acuity (UCVA) and Best Spectacle Corrected Visual Acuity (BSCVA) at distance (4 meters) and near at preferred distance and measured by logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity.

Recruitment status

COMPLETED

Target enrollment

146 participants

Primary outcome timeframe

1 week to 10 months

Results posted on

2017-03-27

Participant Flow

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

Subjects eligibility was determined at the preoperative visit.

Participant milestones

Participant milestones
Measure	ReSTOR Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
Overall Study STARTED	146
Overall Study COMPLETED	146
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Surgeon Experience ReSTOR A +4 Intraocular Lens (IOL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ReSTOR n=146 Participants Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
Age, Customized <=18 years	0 participants n=113 Participants
Age, Customized Between 18 and 65 years	65 participants n=113 Participants
Age, Customized >=65 years	59 participants n=113 Participants
Sex/Gender, Customized Female	79 participants n=113 Participants
Sex/Gender, Customized Male	54 participants n=113 Participants

PRIMARY outcome

Timeframe: 1 week to 10 months

Outcome measures

Outcome measures
Measure	ReSTOR n=146 Participants Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
Visual Acuity Near (preferred distance) BSCVA	0.06 logMAR Standard Deviation 0.11
Visual Acuity Distance (4 meters) UCVA	0.07 logMAR Standard Deviation 0.12
Visual Acuity Near (preferred distance) UCVA	0.07 logMAR Standard Deviation 0.11
Visual Acuity Distance (4 meters) BSCVA	0.02 logMAR Standard Deviation 0.10

SECONDARY outcome

Timeframe: 1 week to 10 months

Population: contrast sensitivity data was received for only 51 of 146 patients.

Contrast sensitivity is the measurement of how faded an image may become before it is indistinguishable. Contrast sensitivity was measured in photopic, mesopic, and mesopic with glare conditions at the following spatial frequencies: 1.5, 3, 6, 12, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity.

Outcome measures

Outcome measures
Measure	ReSTOR n=51 Participants Implantation with the AcrySof ReSTOR Aspheric +4 Intraocular Lens (IOL)
Contrast Sensitivity Photopic condition at 1.5 cpd	1.61 log units Standard Deviation 0.31
Contrast Sensitivity Photopic condition at 3 cpd	1.78 log units Standard Deviation 0.32
Contrast Sensitivity Photopic condition at 6 cpd	1.72 log units Standard Deviation 0.44
Contrast Sensitivity Photopic condition at 12 cpd	1.22 log units Standard Deviation 0.53
Contrast Sensitivity Photopic condition at 18 cpd	0.70 log units Standard Deviation 0.57
Contrast Sensitivity Mesopic condition at 1.5 cpd	1.69 log units Standard Deviation 0.30
Contrast Sensitivity Mesopic condition at 3 cpd	1.69 log units Standard Deviation 0.32
Contrast Sensitivity Mesopic condition at 6 cpd	1.43 log units Standard Deviation 0.57
Contrast Sensitivity Mesopic condition at 12 cpd	0.66 log units Standard Deviation 0.67
Contrast Sensitivity Mesopic condition at 18 cpd	0.25 log units Standard Deviation 0.45
Contrast Sensitivity Mesopic with glare condition at 1.5 cpd	1.29 log units Standard Deviation 0.52
Contrast Sensitivity Mesopic with glare condition at 3 cpd	1.28 log units Standard Deviation 0.58
Contrast Sensitivity Mesopic with glare condition at 6 cpd	0.92 log units Standard Deviation 0.74
Contrast Sensitivity Mesopic with glare condition at 12 cpd	0.27 log units Standard Deviation 0.57
Contrast Sensitivity Mesopic with glare condition at 18 cpd	0.07 log units Standard Deviation 0.27

Adverse Events

ReSTOR

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

Restriction type: OTHER