Visual Function With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00710931
• Collaborator: (none)
• Enrollment: 35
• Location: 1
• Arm: 1
• Duration (Months): 23
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

The objective of this study is to prospectively evaluate the visual parameters in a series of patients after phacoemulsification cataract surgery in a series of patients bilaterally implanted with the AcrySof® ReSTOR® Aspheric +3.0 Intraocular Lens (IOL).

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: AcrySof ReSTOR Aspheric IOL model SN6AD1	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Visual Function With Bilateral AcrySof® ReSTOR® Aspheric SN6AD1
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ReSTOR +3 Multifocal Lens Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)	Device: AcrySof ReSTOR Aspheric IOL model SN6AD1; Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL) following cataract removal.

Outcome Measures

Primary Outcome Measures

1. Binocular Visual Acuity at Distance, Near and Intermediate [6 months after surgery]

   Uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m), 60 centimeters (cm), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Prospective subjects should be 21 years of age and older, be of any race and gender and meet study entry criteria. Subject must require extraction of cataracts followed by implantation of a posterior chamber intraocular lens (IOL). Subjects must be candidates for bilateral removal of the natural crystalline lens followed by implantation of a multifocal IOL and be willing and able to complete all follow-up visits.

Exclusion Criteria:

• Subjects with pre-existing conditions that could skew the results or are contraindications for the AcrySof® ReSTOR® IOL should be excluded from the study. Please consult the AcrySof® ReSTOR® Aspheric product inserts under "Precautions" for subject groups that should be excluded from this study.

All subjects must have ≤ 0.75 diopters of astigmatism preoperatively as measured by Keratometry (K) readings. If the surgeon determines that a correction of cylinder is necessary postoperatively, this may be performed after the three month evaluations are completed.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Contact 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.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00710931
• Other Study ID Numbers: ALCONsur001.08
• First Posted: Jul 8, 2008
• Last Update Posted: Dec 12, 2011
• Last Verified: Dec 1, 2011

• Keywords provided by Alcon Research: Bilateral Cataract; IOL; ReSTOR; Aspheric
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Arm/Group Title	ReSTOR +3 Multifocal Lens
Arm/Group Description	Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
Period Title: Overall Study
STARTED	34
COMPLETED	29
NOT COMPLETED	5

Baseline Characteristics

Arm/Group Title	ReSTOR +3 Multifocal Lens
Arm/Group Description	Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
Overall Participants	34
Age (years) [Median (Standard Deviation) ]
Median (Standard Deviation) [years]	74.5 (6.44)
Sex: Female, Male (Count of Participants)
Female	18 52.9%
Male	16 47.1%

Outcome Measures

1. Primary Outcome

Title	Binocular Visual Acuity at Distance, Near and Intermediate
Description	Uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m), 60 centimeters (cm), and near at preferred distance (distance chosen by each subject and recorded in cm; mean and standard deviation calculated) with a standard ETDRS chart for distance and a hand held chart for near. VA is measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". A lower logMAR value indicates better VA.
Time Frame	6 months after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ReSTOR +3 Multifocal Lens
Arm/Group Description	Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
Measure Participants	34
Uncorrected VA at 4 m	0.00 (0.08)
Uncorrected VA at 60 cm	0.13 (0.11)
Uncorrected VA best near (39.69 cm +/- 4.09 cm)	0.07 (0.08)
Best Corrected VA at 4 m	0.00 (0.06)
Best Corrected VA at 60 cm	0.09 (0.11)
Best Corrected VA best near (41.31 cm +/- 5.82 cm)	0.07 (0.08)

Adverse Events

Adverse Event Reporting Description	Adverse events were not collected in this study.
Arm/Group Title	ReSTOR +3 Multifocal Lens
Arm/Group Description	Bilateral implantation of the AcrySof ReSTOR +3 Intraocular Lens (IOL)
All Cause Mortality
	ReSTOR +3 Multifocal Lens
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	ReSTOR +3 Multifocal Lens
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	ReSTOR +3 Multifocal Lens
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

When a clinical study report or manuscript, in lieu of a final report, is completed, Alcon will provide the summary findings of the study to the investigator.