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Trial Outcomes & Findings for Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL (NCT NCT00759096)

NCT ID: NCT00759096

Last Updated: 2023-12-05

Results Overview

Near uncorrected visual acuity(UCVA) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution and is used to measure visual acuity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

6 months after surgery of 2nd eye

Results posted on

2023-12-05

Participant Flow

Eligible patients with bilateral cataract were implanted with ReSTOR lens and followed up for 6-month after the 2nd eye implantation

Open-label, single arm and nonrandomized

Participant milestones

Participant milestones
Measure
AcrySof ReSTOR IOL
Acrysof ReSTOR Intraocular Lens (IOL)
Overall Study
STARTED
30
Overall Study
COMPLETED
30
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Assessment of Visual Function With the Acrysof ReSTOR Multifocal IOL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
AcrySof ReSTOR IOL
n=30 Participants
Acrysof ReSTOR Intraocular Lens (IOL)
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
3 Participants
n=5 Participants
Age, Categorical
>=65 years
27 Participants
n=5 Participants
Sex: Female, Male
Female
22 Participants
n=5 Participants
Sex: Female, Male
Male
8 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 6 months after surgery of 2nd eye

Near uncorrected visual acuity(UCVA) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution and is used to measure visual acuity.

Outcome measures

Outcome measures
Measure
AcrySof ReSTOR IOL
n=30 Participants
Acrysof ReSTOR Intraocular Lens (IOL)
Near Uncorrected Visual Acuity(UCVA
0.5 logMAR
Standard Deviation 0.12

SECONDARY outcome

Timeframe: 6 months after sugery of the 2nd eye

Outcome measures

Outcome data not reported

Adverse Events

AcrySof ReSTOR 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

Benny Li, PhD

Alcon Research, Ltd.

Phone: +86 21 6375 8762

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place