Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3

• Sponsor: Alcon Research (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00710905
• Collaborator: (none)
• Enrollment: 50
• Locations: 2
• Arm: 1
• Duration (Months): 11
• Patients Per Site: 25
• Patients Per Site Per Month: 2.3

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 Intraocular Lens (IOL) Models SN6AD1 And SN6AD3.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: AcrySof ReSTOR Aspheric IOL models SN6AD1 and SN6AD3	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ReSTOR Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.	Device: AcrySof ReSTOR Aspheric IOL models SN6AD1 and SN6AD3; Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, AcrySof ReSTOR +4 IOL in the other eye following cataract removal.

Outcome Measures

Primary Outcome Measures

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

   Binocular uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m) (distance), 60 centimeters (cm) (intermediate), 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. Scores were calculated using logMAR values. 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	Dr John Blaylock	Abbotsford	British Columbia	Canada	V2S 5A1
2	Dr Dominique Meyer	Quebec City	Quebec	Canada	G1S 1X6

Sponsors and Collaborators

• Alcon Research

Investigators

• Principal Investigator: John Blaylock,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT00710905
• Other Study ID Numbers: ALCONsur002.08
• First Posted: Jul 8, 2008
• Last Update Posted: Nov 24, 2011
• Last Verified: Nov 1, 2011

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

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	ReSTOR
Arm/Group Description	Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
Period Title: Overall Study
STARTED	50
COMPLETED	34
NOT COMPLETED	16

Baseline Characteristics

Arm/Group Title	ReSTOR
Arm/Group Description	Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
Overall Participants	50
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	29 58%
>=65 years	21 42%
Gender (participants) [Number]
Female	24 48%
Male	25 50%

Outcome Measures

1. Primary Outcome

Title	Binocular Visual Acuity at Near, Intermediate and Distance
Description	Binocular uncorrected and best corrected visual acuity (VA) was tested at 4 meters (m) (distance), 60 centimeters (cm) (intermediate), 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. Scores were calculated using logMAR values. 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
Arm/Group Description	Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
Measure Participants	34
Uncorrected distance VA (4 m)	0.02 (0.08)
Uncorrected intermediate VA (60 cm)	0.31 (0.11)
Uncorrected best near VA (34.11 cm +/- 4.23 cm)	-0.02 (0.10)
Best corrected distance VA (4 m)	-0.04 (0.07)
Best corrected intermediate VA (60 cm)	0.31 (0.15)
Best corrected best near VA (34.17 cm +/- 4.40 cm)	-0.01 (0.10)

Adverse Events

Time Frame	Surgical visit until 6 months after surgery.
Arm/Group Title	ReSTOR
Arm/Group Description	Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, Acrysof ReSTOR +4 IOL in the other eye.
All Cause Mortality
	ReSTOR
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	ReSTOR
	Affected / at Risk (%)	# Events
Total	1/50 (2%)
Eye disorders
Retinal Detachment	1/50 (2%)	1
Other (Not Including Serious) Adverse Events
	ReSTOR
	Affected / at Risk (%)	# Events
Total	8/50 (16%)
Eye disorders
Posterior Capsule Opacification	4/50 (8%)	5
Visual disturbances	2/50 (4%)	2
Allergic Reaction	1/50 (2%)	1
Redness	1/50 (2%)	1

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.