Visual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis or Acri.LISA

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00721253
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 3
• Duration (Months): 15
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

This is a study to compare visual outcomes of subjects bilaterally implanted w/ReSTOR to subjects bilaterally implanted with the Tecnis Multifocal Intraocular Lens (IOL) or Acri.LISA IOL

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: ReSTOR; Device: Tecnis; Device: Acri.LISA	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Visual Outcomes of Subjects Bilaterally Implanted With ReSTOR Aspheric +4 vs. Tecnis Multifocal Intraocular Lens (IOL) or Acri.LISA IOL
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ReSTOR Aspheric +4 ACRYSOF ReSTOR Aspheric +4 Model SN6AD3	Device: ReSTOR; Implantation of the ReSTOR Aspheric +4 (SN6AD3) multifocal intraocular lens (IOL)
Active Comparator: Tecnis MF Abbott Medical Optics Tecnis Multifocal Intraocular Lens (IOL) Model ZM900	Device: Tecnis; Implantation with the Tecnis multifocal (ZM900) intraocular lens (IOL)
Active Comparator: Acri.LISA Meditec Acri.LISA Intraocular Lens (IOL) Model 366D	Device: Acri.LISA; Implantation with the Acri.LISA 366D multifocal intraocular lens (IOL)

Outcome Measures

Primary Outcome Measures

1. Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate [6 months]

   Uncorrected Visual Acuity (UCVA) at distance, near and intermediate, measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA). A lower logMAR value indicates better visual acuity.

Secondary Outcome Measures

1. Contrast Sensitivity [6 months]

   Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.

2. Defocus Curve [6 months post-operative]

   Defocus cureve. A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers. 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 and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Diagnosed with cataracts

Exclusion Criteria:

• Preexisting condition likely to confound results; 1 D astigmatism by preoperative K-readings

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.

• ClinicalTrials.gov Identifier: NCT00721253
• Other Study ID Numbers: M07-002
• First Posted: Jul 24, 2008
• Last Update Posted: Mar 16, 2010
• Last Verified: Mar 1, 2010

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

Study Results

Participant Flow

Recruitment Details	Subjects 18 years or older of either sex and any race; bilateral diagnosis of cataracts. There were no patients that received implantation of the Tecnis Multifocal lens.
Pre-assignment Detail	Subject eligibility was determined at the pre-operative visit.

Arm/Group Title	ReSTOR Aspheric +4	Acri LISA IOL	Tecnis MF
Arm/Group Description	Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3	Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D	Abbott Medical Optics Tecnis Multifocal Intraocular Lens (IOL) Model ZM900
Period Title: Overall Study
STARTED	20	22	0
COMPLETED	20	22	0
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	ReSTOR Aspheric +4	Acri LISA IOL	Total
Arm/Group Description	Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3	Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D	Total of all reporting groups
Overall Participants	20	22	42
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	12 60%	21 95.5%	33 78.6%
>=65 years	8 40%	1 4.5%	9 21.4%
Sex: Female, Male (Count of Participants)
Female	12 60%	15 68.2%	27 64.3%
Male	8 40%	7 31.8%	15 35.7%

Outcome Measures

1. Primary Outcome

Title	Uncorrected Visual Acuity (UCVA) at Distance, Near and Intermediate
Description	Uncorrected Visual Acuity (UCVA) at distance, near and intermediate, measured in logMAR. LogMAR is the "logarithm of the minimum angle of resolution". It is a unit of measure for visual acuity (VA). 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 +4	Acri LISA IOL
Arm/Group Description	Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3	Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
Measure Participants	20	22
UCVA 4 m	0.02 (0.13)	0.01 (0.18)
UCVA 80 cm	0.20 (0.14)	0.20 (0.15)
UCVA 60 cm	0.21 (0.14)	0.19 (0.14)
UCVA Near at 40 cm	-0.04 (0.18)	-0.05 (0.07)

2. Secondary Outcome

Title	Contrast Sensitivity
Description	Contrast sensitivity is the measurement of one's ability to detect slight changes in luminance before it becomes indistinguishable. It is measured in logarithmic units by means of an illuminated box, the CSV 1000 by Vector Vision. A higher value for the logarithmic units translates to better contrast sensitivity.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ReSTOR Aspheric +4	Acri LISA IOL
Arm/Group Description	Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3	Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
Measure Participants	20	22
Contrast Sensitivity 1.5 cpd (cycles per degree)	1.88 (0.20)	1.78 (0.27)
Contrast Sensitivity 3 cpd	1.98 (0.23)	2.01 (0.15)
Contrast Sensitivity 6 cpd	1.94 (0.24)	1.99 (0.16)
Contrast Sensitivity 12 cpd	1.57 (0.31)	1.53 (0.22)
Contrast Sensitivity 18 cpd	1.02 (0.42)	1.07 (0.30)
Mesopic Conditions, 1.5 cpd	1.87 (0.21)	1.83 (0.15)
Mesopic Conditions, 3 cpd	1.91 (0.22)	1.83 (0.16)
Mesopic Conditions, 6 cpd	1.68 (0.23)	1.62 (0.25)
Mesopic Conditions, 12 cpd	1.11 (0.36)	1.16 (0.36)
Mesopic Conditions, 18 cpd	0.54 (0.26)	0.52 (0.22)
Mesopic Conditions w/glare, 1.5 cpd	1.56 (0.37)	1.55 (0.31)
Mesopic Conditions w/glare, 3 cpd	1.56 (0.39)	1.52 (0.24)
Mesopic Conditions w/glare, 6 cpd	1.31 (0.34)	1.26 (0.24)
Mesopic Conditions w/glare, 12 cpd	0.72 (0.26)	0.73 (0.19)
Mesopic Conditions w/glare, 18 cpd	0.34 (0.13)	0.30 (0.00)

3. Secondary Outcome

Title	Defocus Curve
Description	Defocus cureve. A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers. 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 post-operative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ReSTOR Aspheric +4	Acri LISA IOL
Arm/Group Description	Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3	Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
Measure Participants	20	22
Negative Defocus Curve, -5.0 Diopter	0.55 (0.13)	0.58 (0.12)
Negative Defocus Curve, -4.5 Diopter	0.38 (0.10)	0.42 (0.13)
Negative Defocus Curve, -4.0 Diopter	0.24 (0.14)	0.27 (0.12)
Negative Defocus Curve, -3.5 Diopter	0.08 (0.08)	0.08 (0.11)
Negative Defocus Curve, -3.0 Diopter	0.0 (0.08)	0.02 (0.09)
Negative Defocus Curve, -2.5 Diopter	0.09 (0.12)	0.08 (0.11)
Negative Defocus Curve, -2.0 Diopter	0.29 (0.13)	0.27 (0.16)
Negative Defocus Curve, -1.5 Diopter	0.31 (0.15)	0.32 (0.14)
Negative Defocus Curve, -1.0 Diopter	0.21 (0.14)	0.17 (0.12)
Negative Defocus Curve, -0.5 Diopter	0.06 (0.11)	0.02 (0.10)
Negative Defocus Curve, 0.0 Diopter	-0.08 (0.07)	-0.10 (0.08)
Positive Defocus Curve, 2.0 Diopter	0.61 (0.11)	0.57 (0.13)
Positive Defocus Curve, 1.5 Diopter	0.45 (0.13)	0.44 (0.12)
Positive Defocus Curve, 1.0 Diopter	0.26 (0.13)	0.27 (0.12)
Positive Defocus Curve, 0.5 Diopter	0.03 (0.11)	0.02 (0.13)
Positive Defocus Curve, 0.0 Diopter	-0.08 (0.08)	-0.09 (0.08)

Adverse Events

Adverse Event Reporting Description	There were no adverse events to report.
Arm/Group Title	ReSTOR Aspheric +4		Acri LISA IOL
Arm/Group Description	Bilateral implantation of ACRYSOF ReSTOR Aspheric +4 Model SN6AD3		Bilateral Implantation of Meditec Acri.LISA Intraocular Lens (IOL) Model 366D
All Cause Mortality
	ReSTOR Aspheric +4		Acri LISA IOL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	ReSTOR Aspheric +4		Acri LISA IOL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	ReSTOR Aspheric +4		Acri LISA IOL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/22 (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.