Trial Outcomes & Findings for Visual Function After Bilateral Implantation of AcrySof® Toric (NCT NCT00758550)

Results Overview

Uncorrected Visual Acuity (UCVA) from surgery 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

60 participants

Primary outcome timeframe

6 Months after surgery

Results posted on

2010-03-16

Participant Flow

60 cataract patients were enrolled into the study

Randomized

Participant milestones

Participant milestones
Measure	AcrySof Toric IOL AcrySof Toric Intraocular Lens	AcrySof Natural IOL AcrySof Natural Intraocular Lens
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Visual Function After Bilateral Implantation of AcrySof® Toric

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AcrySof Toric IOL n=30 Participants AcrySof Toric Intraocular Lens	AcrySof Natural IOL n=30 Participants AcrySof Natural Intraocular Lens	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	15 Participants n=7 Participants	27 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	15 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	16 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	14 Participants n=7 Participants	27 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months after surgery

Uncorrected Visual Acuity (UCVA) from surgery 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	AcrySof Toric IOL n=30 Participants AcrySof Toric Intraocular Lens	AcrySof Natural IOL n=30 Participants AcrySof Natural Intraocular Lens
Uncorrected Visual Acuity (UCVA)	0.06 logMAR Standard Deviation 0.14	0.14 logMAR Standard Deviation 0.11

SECONDARY outcome

Timeframe: 6 Months

Results of questionnaire rating the quality of distance vision without glasses or contact lenses. Measured on a scale of 0 to 6 (0 = worst, 6 = best).

Outcome measures

Outcome measures
Measure	AcrySof Toric IOL n=30 Participants AcrySof Toric Intraocular Lens	AcrySof Natural IOL n=30 Participants AcrySof Natural Intraocular Lens
Questionnaire Results	5.6 Units on a scale Standard Error 0.7	4.5 Units on a scale Standard Error 0.7

Adverse Events

AcrySof Toric IOL

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AcrySof Natural 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