ReSTOR Natural +3.0D Study In Japan

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00758576
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arm: 1
• Duration (Months): 22
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate safety and effectiveness of ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1 when implanted to replace the natural lens following cataract removal.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: ReSTOR Natural +3.0D (Diopter) Study In Japan
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SN6AD1 AcrySof ReSTOR Model SN6AD1 Intraocular Lens	Device: ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1; Implantation with the AcrySof ReSTOR Intraocular Lens (IOL) Model SN6AD1 following cataract removal.

Outcome Measures

Primary Outcome Measures

1. Uncorrected Intermediate Visual Acuity [1 year after surgery]

   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.

2. Uncorrected Distance Visual Acuity [1 year after surgery]

   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.

3. Uncorrected Near Visual Acuity [1 year after surgery]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Planned bilateral cataract removal by phacoemulsification

• Potential postoperative best corrected visual acuity of 0.5 or over

• 1.5 Diopter (D) or less of astigmatism preoperatively, measured by keratometry

Exclusion Criteria:

• Poorly controlled glaucoma

• Progressive diabetic retinopathy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hayashi Eye Hospital	Fukuoka		Japan	812-0011

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00758576
• Other Study ID Numbers: C-07-44
• First Posted: Sep 25, 2008
• Last Update Posted: Dec 21, 2010
• Last Verified: Dec 1, 2010

• Keywords provided by , ,: Cataract
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Recruitment Details	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
Pre-assignment Detail	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.

Arm/Group Title	SN6AD1
Arm/Group Description	ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
Period Title: Overall Study
STARTED	64
COMPLETED	63
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	SN6AD1
Arm/Group Description	ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
Overall Participants	64
Age, Customized (Number) [Number]
<60 years of age	6 9.4%
60 - 69 years of age	23 35.9%
70 - 79 years of age	33 51.6%
>80 years of age	2 3.1%
Sex: Female, Male (Count of Participants)
Female	60 93.8%
Male	4 6.3%

Outcome Measures

1. Primary Outcome

Title	Uncorrected Intermediate Visual Acuity
Description	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.
Time Frame	1 year after surgery

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SN6AD1
Arm/Group Description	ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
Measure Participants	63
1 meter	0.771
50 centimeters	0.861

2. Primary Outcome

Title	Uncorrected Distance Visual Acuity
Description	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.
Time Frame	1 year after surgery

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SN6AD1
Arm/Group Description	ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
Measure Participants	63
Mean (Full Range) [Decimal Visual Acuity]	1.122

3. Primary Outcome

Title	Uncorrected Near Visual Acuity
Description	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.
Time Frame	1 year after surgery

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SN6AD1
Arm/Group Description	ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
Measure Participants	63
Mean (Full Range) [Decimal Visual Acuity]	1.082

Adverse Events

Time Frame	From time of surgery to 1 year following surgery.
Arm/Group Title	SN6AD1
Arm/Group Description	ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
All Cause Mortality
	SN6AD1
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	SN6AD1
	Affected / at Risk (%)	# Events
Total	1/64 (1.6%)
Nervous system disorders
Stroke	1/64 (1.6%)	1
Other (Not Including Serious) Adverse Events
	SN6AD1
	Affected / at Risk (%)	# Events
Total	0/64 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.