Contralateral ReSTOR / Monofocal or Phakic Eye

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00731640
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

Bilateral evaluation of unilateral implantation of ReSTOR and contralateral monofocal or phakic eye.

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Outcomes With AcrySof ReSTOR Aspheric Apodized Diffractive Intraocular Lens (IOL) in One Eye and a Contralateral Monofocal IOL or Phakic Eye
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Monofocal Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular lens (IOL) (unspecified) in other eye	Device: ReSTOR; AcrySof ReSTOR +4 Intraocular Lens (IOL) unilaterally implanted
Active Comparator: Phakic Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending	Device: ReSTOR; AcrySof ReSTOR +4 Intraocular Lens (IOL) unilaterally implanted

Outcome Measures

Primary Outcome Measures

1. Visual Acuity [6 months]

   Uncorrected 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.

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 (log) 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. Patient Satisfaction [6 Months Postoperative]

   Average rating of patient satisfaction based on a patient survey. The survey had a 10 point scale (10 being most satisfied and 0 being most unsatisfied).

3. Spectacle Independence [6 Months]

   The percentage of patients reporting spectacle independence (no longer needing to wear glasses).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Unilateral operable cataract

• Candidate for presbyopic intraocular lens (IOL)

Exclusion Criteria:

• Ocular comorbidities compromising primary outcome

• Bilateral cataracts

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: NCT00731640
• Other Study ID Numbers: M07-012
• First Posted: Aug 11, 2008
• Last Update Posted: Mar 23, 2010
• Last Verified: Mar 1, 2010

• Keywords provided by , ,: AcrySof; ReSTOR; Multifocal; Intraocular Lens
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Recruitment Details	This is a retrospective study that required patients with unilateral implantation of the AcrySof ReSTOR Intraocular Lens (IOL). Patients were to be free of conditions or ocular co-morbidities that may affect visual acuity.
Pre-assignment Detail	During the preoperative exam, subjects were examined to ensure they met the inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study by meeting all inclusion/exclusion criteria were enrolled. This study was not randomized.

Arm/Group Title	Monofocal	Phakic
Arm/Group Description	Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye	Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
Period Title: Overall Study
STARTED	20	32
COMPLETED	20	32
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Monofocal	Phakic	Total
Arm/Group Description	Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye	Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending	Total of all reporting groups
Overall Participants	20	32	52
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	8 40%	23 71.9%	31 59.6%
>=65 years	12 60%	9 28.1%	21 40.4%
Sex: Female, Male (Count of Participants)
Female	9 45%	13 40.6%	22 42.3%
Male	11 55%	19 59.4%	30 57.7%

Outcome Measures

1. Primary Outcome

Title	Visual Acuity
Description	Uncorrected 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	Monofocal	Phakic
Arm/Group Description	Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye	Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
Measure Participants	20	32
Distance	-0.04 (0.09)	-0.01 (0.09)
Intermediate	0.14 (0.13)	0.18 (0.15)
Near (Preferred Distance)	0.04 (0.10)	0.09 (0.12)

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 (log) 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	Monofocal	Phakic
Arm/Group Description	Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye	Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
Measure Participants	20	32
Photopic CS, 3 cycles per degree (cpd)	1.95 (0.13)	1.90 (0.13)
Mesopic CS, 3 cpd	1.85 (0.18)	1.84 (0.19)
Mesopic w/Glare CS, 3 cpd	1.82 (0.18)	1.81 (0.22)
Photopic CS, 6 cpd	2.10 (0.24)	2.05 (0.20)
Mesopic CS, 6 cpd	1.76 (0.36)	1.62 (0.39)
Mesopic w/Glare CS, 6 cpd	1.73 (0.23)	1.57 (0.56)
Photopic CS, 12 cpd	1.78 (0.26)	1.66 (0.27)
Mesopic CS, 12 cpd	1.18 (0.51)	0.95 (0.51)
Mesopic w/Glare CS, 12 cpd	1.21 (0.38)	0.88 (0.54)
Photopic CS, 18 cpd	1.18 (0.39)	1.14 (0.31)
Mesopic CS, 18 cpd	0.61 (0.52)	0.49 (0.58)
Mesopic w/Glare CS, 18 cpd	0.57 (0.41)	0.40 (0.52)

3. Secondary Outcome

Title	Patient Satisfaction
Description	Average rating of patient satisfaction based on a patient survey. The survey had a 10 point scale (10 being most satisfied and 0 being most unsatisfied).
Time Frame	6 Months Postoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Monofocal	Phakic
Arm/Group Description	Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye	Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
Measure Participants	20	32
Mean (Standard Deviation) [Units on a Scale]	6.85 (2.41)	7.63 (2.24)

4. Secondary Outcome

Title	Spectacle Independence
Description	The percentage of patients reporting spectacle independence (no longer needing to wear glasses).
Time Frame	6 Months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Monofocal	Phakic
Arm/Group Description	Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye	Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
Measure Participants	20	32
Number [Percentage of Participants]	65 325%	56 175%

Adverse Events

Arm/Group Title	Monofocal		Phakic
Arm/Group Description	Patients unilaterally implanted with ReSTOR lens in one eye and previously implanted with monofocal Intraocular Lens (IOL) (unspecified) in other eye		Patients unilaterally implanted with ReSTOR lens in one eye and phakic in the other eye with no necessary cataract removal impending
All Cause Mortality
	Monofocal		Phakic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Monofocal		Phakic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	Monofocal		Phakic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/32 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Specify: No paper that incorporates Sponsor Confidential Information will be submitted for publication without Sponsor's prior written agreement.