Trial Outcomes & Findings for ACRYSOF® Toric NATURAL T9 Intraocular Lens (IOL) (NCT NCT00967473)

Results Overview

Rates of spatial distortions were evaluated by use of the Visual Distortion Questionnaire (VDQ). The VDQ evaluates the rate \& frequency of subjects' experiences with potential visual distortions. The fewer the patients that report visual distortions, the better. The VDQ is a binocular assessment, therfore the subject will use both eyes to evaluate visual distortions.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

Before Surgery and 180 days after second eye implant

Results posted on

2017-01-09

Participant Flow

Participant milestones

Participant milestones
Measure	Toric Intraocular Lens ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ACRYSOF® Toric NATURAL T9 Intraocular Lens (IOL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Toric Intraocular Lens n=15 Participants ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Gender Female	12 Participants n=5 Participants
Gender Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Before Surgery and 180 days after second eye implant

Population: Per protocol, one subject was excluded from this analysis due to a secondary surgical intervention.

Rates of spatial distortions were evaluated by use of the Visual Distortion Questionnaire (VDQ). The VDQ evaluates the rate \& frequency of subjects' experiences with potential visual distortions. The fewer the patients that report visual distortions, the better. The VDQ is a binocular assessment, therfore the subject will use both eyes to evaluate visual distortions.

Outcome measures

Outcome measures
Measure	Toric Intraocular Lens n=14 Participants ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
Number of Subjects Reporting Spatial Distortions Related to Intraocular Lens (IOL) Misalignment Before Surgery	11 Participants
Number of Subjects Reporting Spatial Distortions Related to Intraocular Lens (IOL) Misalignment After Surgery	2 Participants

PRIMARY outcome

Timeframe: 6 months after surgery on second eye

Population: All implanted subjects were included in this analysis.

Percentage of subjects with reduction in post-operative refractive cylinder (amount of astigmatism) compared to pre-operative keratometric cylinder in the study eye. The post-operative refractive cylinder should be significantly lower than it was pre-operatively.

Outcome measures

Outcome measures
Measure	Toric Intraocular Lens n=15 Participants ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
Reduction of Cylinder	85.67 Percent reduction of cylinder Interval 77.04 to 94.3

PRIMARY outcome

Timeframe: Time of surgery

Population: All implanted subjects were included in this analysis.

Comparison of where the surgeon intended to place the lens axis versus final placement of the lens during the surgical procedure, measured in degrees. This number should be close to zero as there should be minimal difference between the two numbers. This assessment is only for the study eye.

Outcome measures

Outcome measures
Measure	Toric Intraocular Lens n=15 Participants ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
Lens Axis Misalignment	0.3 Degrees Interval 0.0 to 2.0

Adverse Events

Toric Intraocular Lens

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Toric Intraocular Lens n=15 participants at risk ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
Eye disorders Secondary Surgical Intervention	6.7% 1/15 • Number of events 1 • 6 months

Other adverse events

Adverse event data not reported

Additional Information

Director of Alcon Clinical

Alcon Research, Ltd.

Phone: 888-451-3937; 817-568-6725

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Per clinical protocol confidentiality/study publication specifications all data discoveries arising out of the study, patentable of nonpatentable, shall be the sole property of Alcon Inc. Alcon reserves the right of prior review of any publication or presentation of information related to the study.
Publication restrictions are in place

Restriction type: OTHER