Trial Outcomes & Findings for Low Cylinder Toric (NCT NCT00732030)

Results Overview

Uncorrected Distance Visual Acuity at month 6 measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

26 participants

Primary outcome timeframe

6 months

Results posted on

2010-04-07

Participant Flow

Patients were \>21 years of age, of any race and either gender. Patients had operable cataracts in at least 1 eye and were able to provide informed consent. Patients were free of systemic diseases affecting ocular health and had a predicted residual corneal astigmatism between 0.75 and 1.03 Diopters (D) by the AcrySof Toric calculator.

During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study by meeting all inclusion/exclusion criteria were enrolled.

Participant milestones

Participant milestones
Measure	AcrySof Toric T3 Each enrolled eye receives AcrySof Toric SN60T3 IOL
Overall Study STARTED	26
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Low Cylinder Toric

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AcrySof Toric T3 n=26 Participants Each enrolled eye receives AcrySof Toric SN60T3 IOL
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	19 Participants n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Data was collected for 29 eyes in 24 patients.

Uncorrected Distance Visual Acuity at month 6 measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).

Outcome measures

Outcome measures
Measure	AcrySof Toric T3 n=24 Participants Each enrolled eye receives AcrySof Toric SN60T3 IOL
Uncorrected Distance Visual Acuity	0.09 logMAR Standard Deviation 0.14

PRIMARY outcome

Timeframe: 6 Months

Population: Data was collected for 29 eyes in 24 patients.

Best Corrected Distance Visual Acuity at month 6 measured in LogMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA).

Outcome measures

Outcome measures
Measure	AcrySof Toric T3 n=24 Participants Each enrolled eye receives AcrySof Toric SN60T3 IOL
Best Corrected Distance Visual Acuity	0.02 logMAR Standard Deviation 0.09

PRIMARY outcome

Timeframe: 6 Month

Residual Refractive Cylinder at month 6 measured in diopters (D).

Outcome measures

Outcome measures
Measure	AcrySof Toric T3 n=24 Participants Each enrolled eye receives AcrySof Toric SN60T3 IOL
Residual Refractive Cylinder	0.4 Diopters Standard Deviation 0.4

SECONDARY outcome

Timeframe: 6 months

Satisfaction for daytime distance vision, nighttime distance vision, and indoors distance vision on a scale of 1 to 5, with 1 being very dissatisfied and 5 being very satisfied.

Outcome measures

Outcome measures
Measure	AcrySof Toric T3 n=24 Participants Each enrolled eye receives AcrySof Toric SN60T3 IOL
Patient Satisfaction Survey Daytime Distance Vision	4.6 Units on a Scale Standard Deviation 0.6
Patient Satisfaction Survey Nighttime Distance Vision	4.4 Units on a Scale Standard Deviation 0.7
Patient Satisfaction Survey Indoors Distance Vision	4.6 Units on a Scale Standard Deviation 0.7

Adverse Events

AcrySof Toric T3

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