Trial Outcomes & Findings for ReSTOR Natural +3.0D Study In Japan (NCT NCT00758576)

Results Overview

Binocular Uncorrected Intermediate Visual Acuity, measured at 1 meter and 50 centimeters measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

64 participants

Primary outcome timeframe

1 year after surgery

Results posted on

2010-12-21

Participant Flow

Only adult subjects of either gender in need of cataract extraction in both eyes were considered for enrollment. 64 subjects were implanted bilaterally with the ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1

Subjects were examined to ensure inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study were enrolled. Subject numbers were assigned after obtaining consent meeting inclusion/exclusion criteria. Subjects were considered enrolled once implanted in the first operative eye.

Participant milestones

Participant milestones
Measure	SN6AD1 ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
Overall Study STARTED	64
Overall Study COMPLETED	63
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ReSTOR Natural +3.0D Study In Japan

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SN6AD1 n=64 Participants ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
Age, Customized <60 years of age	6 Participants n=5 Participants
Age, Customized 60 - 69 years of age	23 Participants n=5 Participants
Age, Customized 70 - 79 years of age	33 Participants n=5 Participants
Age, Customized >80 years of age	2 Participants n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year after surgery

Population: One patient dropped out after the visit 6 months following surgery but before the 1 year visit.

Binocular Uncorrected Intermediate Visual Acuity, measured at 1 meter and 50 centimeters measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.

Outcome measures

Outcome measures
Measure	SN6AD1 n=63 Participants ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
Uncorrected Intermediate Visual Acuity 1 meter	0.771 Decimal Visual Acuity Interval 0.3 to 1.2
Uncorrected Intermediate Visual Acuity 50 centimeters	0.861 Decimal Visual Acuity Interval 0.5 to 1.2

PRIMARY outcome

Timeframe: 1 year after surgery

Population: One patient dropped out after the visit 6 months following surgery but before the 1 year visit.

Binocular Uncorrected Dinstance Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.

Outcome measures

Outcome measures
Measure	SN6AD1 n=63 Participants ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
Uncorrected Distance Visual Acuity	1.122 Decimal Visual Acuity Interval 0.4 to 2.0

PRIMARY outcome

Timeframe: 1 year after surgery

Population: One patient dropped out after the visit 6 months following surgery but before the 1 year visit.

Binocular Near Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.

Outcome measures

Outcome measures
Measure	SN6AD1 n=63 Participants ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
Uncorrected Near Visual Acuity	1.082 Decimal Visual Acuity Interval 0.6 to 1.9

Adverse Events

SN6AD1

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	SN6AD1 n=64 participants at risk ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
Nervous system disorders Stroke	1.6% 1/64 • Number of events 1 • From time of surgery to 1 year following surgery.

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
Publication restrictions are in place

Restriction type: LTE60