ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL)

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00684138
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 24.9

Study Details

Study Description

Brief Summary

Randomized, parallel group, subject masked, multi-center six (6) month follow-up study comparing ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power IOL Model SN6AD1 implanted in both eyes to ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power IOL Model SN6AD3 implanted in both eyes.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Device: ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens; Device: ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens (IOL)
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: Jun 1, 2008
• Actual Study Completion Date: Jun 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ReSTOR Aspheric +3.0D ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens	Device: ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens; Intraocular Lens
Active Comparator: ReSTOR Aspheric +4.0D ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens	Device: ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens; Intraocular Lens

Outcome Measures

Primary Outcome Measures

1. Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision) [3 months]

   Binocular Distance Corrected Near Visual Acuity at Best Distance (that which provides the subject with the best vision)measured in mean logMAR. logMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). Mean logMAR is the average value of visual acuity.

Secondary Outcome Measures

1. Binocular Distance Corrected Distance Visual Acuity [3 months post-operative]

   Binocular Distance Corrected Distance Visual Acuity measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).

2. Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm) [3 months post-operative]

   Binocular Distance Corrected Intermediate Visual Acuity (tested at 50 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).

3. Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm) [3 months post-operative]

   Binocular Distance Corrected Intermediate Visual Acuity (tested at 60 cm)measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).

4. Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm) [3 months post-operative]

   Binocular Distance Corrected Intermediate Visual Acuity (tested at 70 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).

Eligibility Criteria

Criteria

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

Inclusion:

• Adults, 21 years of age or older at the time of surgery, of either gender or any race, diagnosed with bilateral cataracts

• Calculated lens power is within the available range

• Willing and able to complete all required postoperative visits

• Planned cataract removal by phacoemulsification and/or liquifacture

• Potential postoperative visual acuity of 0.2 logMAR or better in study eyes

• Preoperative astigmatism of 1.0 Diopter (D) or less, measured by keratometry in study eyes

• Clear intraocular media other than cataract in study eyes

• Able to comprehend and sign a statement of informed consent

• Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR, or if BCDVA is equal to or better than 0.2 logMAR, BCDVA with a Brightness Acuity Tester (BAT) on "Medium" setting must be worse than 0.2 logMAR

Exclusion:

• Significant irregular corneal aberration as demonstrated by corneal topography

• Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause future acuity losses to a level worse than 0.2 logMAR

• Subjects who may reasonably be expected to require laser treatments at any time

• Previous corneal refractive surgery

• Amblyopia

• Clinically severe corneal dystrophy (e.g., epithelial, stromal, or endothelial dystrophy)

• Diabetic retinopathy

• Extremely shallow anterior chamber, not due to swollen cataract

• Microphthalmos

• Previous retinal detachment

• Previous corneal transplant

• Recurrent severe anterior or posterior segment inflammation of unknown etiology

• Rubella or traumatic cataract

• Iris neovascularization

• Glaucoma (uncontrolled or controlled with medication)

• Aniridia

• Optic nerve atrophy

• Pregnancy

• Current or previous usage of an alpha-1-selective adrenoceptor blocking agent or an antagonist of alpha 1A adrenoceptor (e.g.Flomax® (tamsulosin HCL), Hytrin®, or Cardura®)

• Any subject currently participating in another investigational drug or device study that may confound the results of this investigation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Call Center for 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: NCT00684138
• Other Study ID Numbers: C-06-40
• First Posted: May 26, 2008
• Last Update Posted: Jul 13, 2010
• Last Verified: Jul 1, 2010

• Keywords provided by , ,: cataract; cataract surgery; IOL; intraocular lens; ReSTOR; Replacement of cataract
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Recruitment Details	Only adult subjects of either gender or any race in need of cataract extraction in both eyes were considered for enrollment. 280 subjects were implanted bilaterally with either the ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power IOL Model SN6AD1 or the ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power IOL Model SN6AD3 based upon a 1:1 randomization.
Pre-assignment Detail	Subjects were examined to ensure inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study were enrolled. Subject numbers were assigned after obtaining consent meeting inclusion/exclusion criteria. Subjects were considered enrolled once implanted in the first operative eye.

Arm/Group Title	ACRYSOF® ReSTOR® +3.0	ACRYSOF® ReSTOR® Aspheric +4.0
Arm/Group Description	ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens	ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Period Title: Overall Study
STARTED	141	139
COMPLETED	138	131
NOT COMPLETED	3	8

Baseline Characteristics

Arm/Group Title	ACRYSOF® ReSTOR® +3.0	ACRYSOF® ReSTOR® Aspheric +4.0	Total
Arm/Group Description	ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens	ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens	Total of all reporting groups
Overall Participants	141	139	280
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	51 36.2%	40 28.8%	91 32.5%
>=65 years	90 63.8%	99 71.2%	189 67.5%
Sex: Female, Male (Count of Participants)
Female	95 67.4%	97 69.8%	192 68.6%
Male	46 32.6%	42 30.2%	88 31.4%

Outcome Measures

1. Primary Outcome

Title	Binocular Distance Corrected Near Visual Acuity at Best Distance (That Which Provides the Subject With the Best Vision)
Description	Binocular Distance Corrected Near Visual Acuity at Best Distance (that which provides the subject with the best vision)measured in mean logMAR. logMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA). Mean logMAR is the average value of visual acuity.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).

Arm/Group Title	ACRYSOF® ReSTOR® +3.0	ACRYSOF® ReSTOR® Aspheric +4.0
Arm/Group Description	ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens	ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Measure Participants	138	131
Mean (95% Confidence Interval) [logMAR]	0.07	0.09

2. Secondary Outcome

Title	Binocular Distance Corrected Distance Visual Acuity
Description	Binocular Distance Corrected Distance Visual Acuity measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).
Time Frame	3 months post-operative

Outcome Measure Data

Analysis Population Description

Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).

Arm/Group Title	ACRYSOF® ReSTOR® +3.0	ACRYSOF® ReSTOR® Aspheric +4.0
Arm/Group Description	ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens	ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Measure Participants	138	131
Mean (95% Confidence Interval) [logMAR]	-0.05	-0.05

3. Secondary Outcome

Title	Binocular Distance Corrected Intermediate Visual Acuity (Tested at 50 cm)
Description	Binocular Distance Corrected Intermediate Visual Acuity (tested at 50 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).
Time Frame	3 months post-operative

Outcome Measure Data

Analysis Population Description

Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).

Arm/Group Title	ACRYSOF® ReSTOR® +3.0	ACRYSOF® ReSTOR® Aspheric +4.0
Arm/Group Description	ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens	ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Measure Participants	138	131
Mean (95% Confidence Interval) [logMAR]	0.06	0.24

4. Secondary Outcome

Title	Binocular Distance Corrected Intermediate Visual Acuity (Tested at 60 cm)
Description	Binocular Distance Corrected Intermediate Visual Acuity (tested at 60 cm)measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).
Time Frame	3 months post-operative

Outcome Measure Data

Analysis Population Description

Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).

Arm/Group Title	ACRYSOF® ReSTOR® +3.0	ACRYSOF® ReSTOR® Aspheric +4.0
Arm/Group Description	ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens	ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Measure Participants	138	131
Mean (95% Confidence Interval) [logMAR]	0.12	0.32

5. Secondary Outcome

Title	Binocular Distance Corrected Intermediate Visual Acuity (Tested at 70 cm)
Description	Binocular Distance Corrected Intermediate Visual Acuity (tested at 70 cm) measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution, which is a measure for visual acuity (VA).
Time Frame	3 months post-operative

Outcome Measure Data

Analysis Population Description

Only patients bilaterally implanted with the test article were considered for the outcome measures. One study lens was removed following implantation, but prior to surgery completion, resulting in 279 subjects who were implanted and available for postoperative follow-up (evaluable for All Implanted Analysis).

Arm/Group Title	ACRYSOF® ReSTOR® +3.0	ACRYSOF® ReSTOR® Aspheric +4.0
Arm/Group Description	ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens	ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens
Measure Participants	138	131
Mean (95% Confidence Interval) [logMAR]	0.18	0.34

Adverse Events

Time Frame	Up to six months after cataract surgery.
Adverse Event Reporting Description	Adverse events were collected from the time of cataract surgery until pre-market approval submission for all 300 patients enrolled in the study.
Arm/Group Title	ACRYSOF® ReSTOR® +3.0 (First Eyes)		ACRYSOF® ReSTOR® Aspheric +4.0 (First Eyes)		ACRYSOF® ReSTOR® +3.0 (Second Eyes)		ACRYSOF® ReSTOR® Aspheric +4.0 (Second Eyes)
Arm/Group Description	ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens - First eye implanted only		ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens - First eye implanted only		ACRYSOF® ReSTOR® Aspheric +3.0 D Add Power Intraocular Lens - Second eye implanted only		ACRYSOF® ReSTOR® Aspheric +4.0 D Add Power Intraocular Lens - Second eye implanted only
All Cause Mortality
	ACRYSOF® ReSTOR® +3.0 (First Eyes)		ACRYSOF® ReSTOR® Aspheric +4.0 (First Eyes)		ACRYSOF® ReSTOR® +3.0 (Second Eyes)		ACRYSOF® ReSTOR® Aspheric +4.0 (Second Eyes)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	ACRYSOF® ReSTOR® +3.0 (First Eyes)		ACRYSOF® ReSTOR® Aspheric +4.0 (First Eyes)		ACRYSOF® ReSTOR® +3.0 (Second Eyes)		ACRYSOF® ReSTOR® Aspheric +4.0 (Second Eyes)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/153 (3.9%)		2/147 (1.4%)		2/151 (1.3%)		3/143 (2.1%)
Eye disorders
Hypopyon	1/153 (0.7%)	1	0/147 (0%)	0	0/151 (0%)	0	0/143 (0%)	0
Endophthalmitis	1/153 (0.7%)	1	0/147 (0%)	0	0/151 (0%)	0	0/143 (0%)	0
Macular Edema	4/153 (2.6%)	4	2/147 (1.4%)	2	0/151 (0%)	0	1/143 (0.7%)	1
Lens Dislocation	1/153 (0.7%)	1	0/147 (0%)	0	0/151 (0%)	0	0/143 (0%)	0
Surgical and medical procedures
Surgical reintervention (SI)	2/153 (1.3%)	5	1/147 (0.7%)	1	2/151 (1.3%)	2	2/143 (1.4%)	2
Other (Not Including Serious) Adverse Events
	ACRYSOF® ReSTOR® +3.0 (First Eyes)		ACRYSOF® ReSTOR® Aspheric +4.0 (First Eyes)		ACRYSOF® ReSTOR® +3.0 (Second Eyes)		ACRYSOF® ReSTOR® Aspheric +4.0 (Second Eyes)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/153 (0%)		0/147 (0%)		0/151 (0%)		0/143 (0%)

Limitations/Caveats

Data from one investigator, who implanted 20 subjects, were excluded from analysis due to non compliance with data collection and documentation. This resulted in 280 implanted subjects that were considered evaluable.

More Information

Certain Agreements

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