Trial Outcomes & Findings for Rotational Stability of the AcrySof® Toric (NCT NCT00762216)

Results Overview

Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

71 participants

Primary outcome timeframe

6 Months post-surgery

Results posted on

2012-10-31

Participant Flow

79 eyes of 71 patients were enrolled into the study. 10 eyes (6 patients) were excluded from analysis for astigmatic keratomy outside of the protocol requirements

non-randomized

Participant milestones

Participant milestones
Measure	Toric Implantation with the AcrySof® Toric intraocular lens
Overall Study STARTED	71
Overall Study COMPLETED	71
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rotational Stability of the AcrySof® Toric

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Toric n=71 Participants Implantation with the AcrySof® Toric intraocular lens
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants
Age, Categorical >=65 years	33 Participants n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 Months post-surgery

Population: 67 eyes (64 patients) were evaluated. Of the original 79 eyes, 10 were excluded from the analysis due to being outside of the protocol specifications. Two (2) additional eyes had no operative intraocular lens (IOL) axis noted on file and were omitted from the analysis of IOL rotation.

Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees.

Outcome measures

Outcome measures
Measure	Toric n=67 Participants Implantation with the AcrySof® Toric intraocular lens
Rotational Stability	4 degrees Standard Error 3

SECONDARY outcome

Timeframe: 6 Months post-surgery

Population: 69 eyes (65 patients) were evaluated. Of the original 79 eyes, 10 were excluded from the analysis due to being outside of the protocol specifications.

The refractive astigmatism 6 months post-surgery, measured in diopters.

Outcome measures

Outcome measures
Measure	Toric n=69 Participants Implantation with the AcrySof® Toric intraocular lens
Residual Refractive Cylinder	0.4 diopters Standard Error 0.4

Adverse Events

Toric

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