Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00719732
• Collaborator: (none)
• Enrollment: 218
• Location: 1
• Arm: 1
• Duration (Months): 20
• Patients Per Site Per Month: 10.9

Study Details

Study Description

Brief Summary

A prospective evaluation of the visual parameters in a series of patients bilaterally implanted with AcrySof ReSTOR +3 Intraocular Lens (IOL).

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: ReSTOR	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 218 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ReSTOR Aspheric +3 Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).	Device: ReSTOR; Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).

Outcome Measures

Primary Outcome Measures

1. Uncorrected Visual Acuity (UCVA) [6 months]

   Uncorrected Visual Acuity (UCVA) measured by means of logMAR at various distances (40 centimeters (cm), 50 cm, 60 cm, 70 cm, and 4 meters (m)). Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Diagnosed with cataracts

Exclusion Criteria:

• Pre-existing conditions that could skew the results or are contraindications for the ReSTOR intraocular lens;

• <1 diopter astigmatism by keratometry readings.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alcon Call Center for Trial Locations	Fort Worth	Texas	United States	76134

Sponsors and Collaborators

• Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00719732
• Other Study ID Numbers: M07-001; NCT00762203
• First Posted: Jul 22, 2008
• Last Update Posted: Mar 16, 2010
• Last Verified: Mar 1, 2010

• Keywords provided by , ,: ReSTOR Aspheric +3 IOL
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Recruitment Details	Subjects 18 - 70 years of age, either sex and any race. Diagnosis of cataracts in one or both eyes.
Pre-assignment Detail	Subject's eligibility was determined at the preoperative visit. All subjects met inclusion/exclusion criteria.

Arm/Group Title	ReSTOR Aspheric +3
Arm/Group Description	Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
Period Title: Overall Study
STARTED	218
COMPLETED	196
NOT COMPLETED	22

Baseline Characteristics

Arm/Group Title	ReSTOR Aspheric +3
Arm/Group Description	Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
Overall Participants	218
Age (participants) [Number]
<=18 years	0 0%
Between 18 and 65 years	143 65.6%
>=65 years	64 29.4%
Gender (participants) [Number]
Female	88 40.4%
Male	124 56.9%

Outcome Measures

1. Primary Outcome

Title	Uncorrected Visual Acuity (UCVA)
Description	Uncorrected Visual Acuity (UCVA) measured by means of logMAR at various distances (40 centimeters (cm), 50 cm, 60 cm, 70 cm, and 4 meters (m)). Visual Acuity (VA) is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better visual acuity.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ReSTOR Aspheric +3
Arm/Group Description	Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
Measure Participants	196
UCVA at 40 cm	0.05 (0.10)
UCVA at 50 cm	-0.07 (0.15)
UCVA at 60 cm	0.15 (0.14)
UCVA at 70 cm	0.20 (0.13)
UCVA at 4 m	-0.01 (0.11)

Adverse Events

Time Frame	Up to 6 months post-operative
Adverse Event Reporting Description	Volunteered and solicited adverse events were collected from the time of surgery to the 6 month post-operative visit.
Arm/Group Title	ReSTOR Aspheric +3
Arm/Group Description	Enrolled subjects receive implantation of ReSTOR +3 intraocular lenses (IOLs) for replacement of cataract in the natural lens of the eye. The patients were to be implanted bilaterally (in both eyes).
All Cause Mortality
	ReSTOR Aspheric +3
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	ReSTOR Aspheric +3
	Affected / at Risk (%)	# Events
Total	1/196 (0.5%)
Eye disorders
Chronic inflammation/iritis	1/196 (0.5%)	1
Other (Not Including Serious) Adverse Events
	ReSTOR Aspheric +3
	Affected / at Risk (%)	# Events
Total	0/196 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

No paper that incorporates Sponsor Condfidential information will be submitted for publication without Sponsor's prior written agreement.