Clinical Investigation of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL)

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01424189
• Collaborator: (none)
• Enrollment: 677
• Arms: 2
• Duration (Months): 18.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of an investigational multifocal toric intraocular lens (IOL) compared to an FDA-approved multifocal IOL.

Condition or Disease	Intervention/Treatment	Phase
Cataracts	Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL; Device: AcrySof® ReSTOR® Multifocal IOL Model SA60D3	N/A

Detailed Description

Participants 21 years and older within the targeted astigmatism range and in need of cataract extraction in both eyes were consented and randomized in a 2:1 ratio at each investigative site to receive either the AcrySof® IQ ReSTOR® Multifocal Toric IOL or the control AcrySof® ReSTOR® Multifocal IOL in both eyes. Each participant completed a preoperative examination of both eyes, implantation of the IOL at the operative visit for each eye, and up to 8 postoperative visits, with monocular testing at Day 1-2, Day 7-14, and Day 30-60 and binocular testing at Day 120-180 and Day 340-420/Visit 5 following the second implantation. The eye with the greater amount of astigmatism was implanted first (first operative eye). The second eye implant was intended to occur within 30 days after the first eye implant but not prior to 7 days after the first eye implant. Both eyes needed to qualify under inclusion/exclusion criteria at the preoperative visit. If the first eye was excluded during surgery, the second eye was not eligible. If the second eye was excluded during surgery, only the first eye was followed.

Study Design

• Study Type: Interventional
• Actual Enrollment: 677 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Investigation of AcrySof® IQ ReSTOR® Multifocal Toric Intraocular Lens Models SND1T3/ SND1T4/ SND1T5/ SND1T6
• Study Start Date: Jul 1, 2011
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ReSTOR Toric IOL AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation	Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL; Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient; Other Names: Models SND1T3, SND1T4, SND1T5, SND1T6
Active Comparator: ReSTOR IOL AcrySof® ReSTOR® Multifocal IOL Model SA60D3, bilateral implantation	Device: AcrySof® ReSTOR® Multifocal IOL Model SA60D3; Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient

Outcome Measures

Primary Outcome Measures

1. Mean Monocular Uncorrected Distance Visual Acuity (UCDVA) at Fixed Distance at Visit 5 [Month 12 from second eye implantation]

   Visual acuity (VA) was measured monocularly (each eye separately) without visual correction using a 100% contrast ETDRS (Early Treatment of Diabetic Retinopathy Study) chart positioned 4 meters (m) from the participant under well-lit conditions. +0.25 diopter (D) spherical power was applied to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.

2. Mean Monocular Uncorrected Near Visual Acuity (UCNVA) at Fixed Distance at Visit 5 [Month 12 from second eye implantation]

   VA was measured monocularly without visual correction using a hand-held ETDRS chart at a fixed distance that differed by lens model implanted. The logMAR ETDRS near visual acuity chart was designed for use at 40 cm; results obtained at other distances were converted to reflect the change in apparent letter size that results from the change in distance. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.

3. Rate of Actual and Potential Secondary Surgical Interventions (SSIs) Related to the Optical Properties of the IOL for First and Second Operative Eyes Separately at Visit 5 [Month 12 from second eye implantation]

   The rate of actual and potential secondary surgical interventions (SSIs) related to the optical properties of the IOL was estimated. If an ocular surgical intervention was performed, it qualified as an actual SSI; however; if the participant met the protocol-specified criteria that would warrant an SSI, but didn't actually undergo the SSI, it qualified as a potential SSI. Rate is presented as percentage of participants.

Secondary Outcome Measures

1. Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5 [Month 12 from second eye implantation]

   Visual disturbances/distortions were reported by the participant on the Assessment of Photic Phenomena and Lens EffectS (APPLES) questionnaire, a Patient Reported Outcome (PRO) questionnaire intended to evaluate 10 distinct visual phenomena associated with cataract extraction and IOL implantation. The first 20 questions addressed both the frequency and severity of the phenomena using a 4-point categorical scale ranging from "never" to "always" (frequency) or "none" to "severe" (severity). The final (21st) question indicated whether the participant answered the questions based on experiences with or without glasses. The participant completed the assessment as a retrospective analysis of the previous week. Rate is presented as the percentage of participants with severity score "severe" for the visual phenomenon.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Diagnosed with bilateral cataracts;

• Able to comprehend and sign a statement of informed consent;

• Calculated lens power and astigmatism within the available range;

• Willing and able to complete all required postoperative visits;

• Planned cataract removal by phacoemulsification;

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

• Preoperative astigmatism in both operative eyes as described in the clinical protocol; Note: Corneal incisions made to reduce astigmatism will not be allowed during the course of the study.

• Clear intraocular media other than cataract in study eyes;

• Preoperative Best Corrected Distance Visual Acuity (BCDVA) worse than 0.2 logMAR in each eye;

• Pupil size greater than or equal to 6 mm after dilation;

• Able to undergo second eye surgery within 30 days of the first eye surgery;

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Significant irregular corneal aberration as demonstrated by corneal topography;

• Keratopathy/Kerectasia - any corneal abnormality, other than regular corneal astigmatism;

• Any inflammation or edema (swelling) of the cornea;

• Diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted (by subjective assessment of the retina) to cause future acuity losses to a level worse than 0.2 logMAR;

• Reasonably expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy);

• 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 participation in another investigational drug or device study that may confound the results of this investigation;

• Other planned ocular surgery procedures, including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions, for the duration of the study;

• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Expert Clinical Project Lead, GCRA, Surgical, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT01424189
• Other Study ID Numbers: C-09-036
• First Posted: Aug 26, 2011
• Last Update Posted: Jun 29, 2018
• Last Verified: May 1, 2018

• Keywords provided by Alcon Research: Cataract surgery; Intraocular lens
• Additional relevant MeSH terms: Cataract

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 21 investigative sites located in the United States.
Pre-assignment Detail	Of the 677 participants enrolled, 103 were exited prior to randomization as screen failures. This reporting population includes all participants with successful IOL implantation in at least 1 eye (574).

Arm/Group Title	ReSTOR Toric IOL	ReSTOR IOL
Arm/Group Description	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation	AcrySof® ReSTOR® Multifocal IOL Model SA60D3, bilateral implantation
Period Title: Overall Study
STARTED	386	188
COMPLETED	373	182
NOT COMPLETED	13	6

Baseline Characteristics

Arm/Group Title	ReSTOR Toric IOL	ReSTOR IOL	Total
Arm/Group Description	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation	AcrySof® ReSTOR® Multifocal IOL Model SA60D3, bilateral implantation	Total of all reporting groups
Overall Participants	386	188	574
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	66.91 (9.20)	68.36 (8.13)	67.38 (8.88)
Sex: Female, Male (Count of Participants)
Female	240 62.2%	136 72.3%	376 65.5%
Male	146 37.8%	52 27.7%	198 34.5%

Outcome Measures

1. Primary Outcome

Title	Mean Monocular Uncorrected Distance Visual Acuity (UCDVA) at Fixed Distance at Visit 5
Description	Visual acuity (VA) was measured monocularly (each eye separately) without visual correction using a 100% contrast ETDRS (Early Treatment of Diabetic Retinopathy Study) chart positioned 4 meters (m) from the participant under well-lit conditions. +0.25 diopter (D) spherical power was applied to correct for optical infinity. VA was measured in logMAR (logarithm of the minimum angle of resolution), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
Time Frame	Month 12 from second eye implantation

Outcome Measure Data

Analysis Population Description

This analysis population includes all participants with successful IOL implantation in the first implanted eye with data at visit.

Arm/Group Title	ReSTOR Toric IOL	ReSTOR IOL
Arm/Group Description	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism	AcrySof® ReSTOR® Multifocal IOL Model SA60D3
Measure Participants	373	180
Measure eyes	373	180
Least Squares Mean (Standard Error) [logMAR]	0.126 (0.013)	0.125 (0.015)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ReSTOR Toric IOL, ReSTOR IOL
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	With 300 subjects in the ReSTOR Toric IOL test group and 150 subjects in the ReSTOR IOL control group, there was over 99% power to demonstrate that the upper 95% confidence limit for the observed difference in UCDVA between IOL groups was less than the clinical performance target of 0.1 logMAR units at Month 12, assuming the true difference between groups is zero. This was based on an assumed standard deviation for UCDVA of 0.16 logMAR units and a 1-sided, α=0.05 test.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.001
	Confidence Interval	(1-Sided) 95%; to 0.030
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.013
	Estimation Comments

2. Primary Outcome

Title	Mean Monocular Uncorrected Near Visual Acuity (UCNVA) at Fixed Distance at Visit 5
Description	VA was measured monocularly without visual correction using a hand-held ETDRS chart at a fixed distance that differed by lens model implanted. The logMAR ETDRS near visual acuity chart was designed for use at 40 cm; results obtained at other distances were converted to reflect the change in apparent letter size that results from the change in distance. VA was measured in logMAR, with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an ETDRS chart. A lower numeric value represents better visual acuity. This analysis was prespecified for the first operative eye.
Time Frame	Month 12 from second eye implantation

Outcome Measure Data

Analysis Population Description

This analysis population includes all participants with successful IOL implantation in the first implanted eye with data at visit.

Arm/Group Title	ReSTOR Toric IOL	ReSTOR IOL
Arm/Group Description	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism	AcrySof® ReSTOR® Multifocal IOL Model SA60D3
Measure Participants	373	180
Mean (Standard Deviation) [logMAR]	0.19 (0.015)	0.24 (0.017)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ReSTOR Toric IOL, ReSTOR IOL
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	With 300 subjects in the ReSTOR Toric IOL test group and 150 subjects in the ReSTOR IOL control group, there was over 99% power to demonstrate that the upper 95% confidence limit for the observed difference in UCNVA between IOL groups was less than the clinical performance target of 0.1 logMAR units at Month 12, assuming the true difference between groups is zero. This estimate was based on an assumed standard deviation for UCNVA of 0.16 logMAR units and a 1-sided, α=0.05 test.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.044
	Confidence Interval	(1-Sided) 95%; to -0.017
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.015
	Estimation Comments

3. Primary Outcome

Title	Rate of Actual and Potential Secondary Surgical Interventions (SSIs) Related to the Optical Properties of the IOL for First and Second Operative Eyes Separately at Visit 5
Description	The rate of actual and potential secondary surgical interventions (SSIs) related to the optical properties of the IOL was estimated. If an ocular surgical intervention was performed, it qualified as an actual SSI; however; if the participant met the protocol-specified criteria that would warrant an SSI, but didn't actually undergo the SSI, it qualified as a potential SSI. Rate is presented as percentage of participants.
Time Frame	Month 12 from second eye implantation

Outcome Measure Data

Analysis Population Description

This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye). For participants with actual SSIs, performance testing outcomes conducted prior to the secondary intervention were carried forward to the final analysis.

Arm/Group Title	ReSTOR Toric IOL	ReSTOR IOL
Arm/Group Description	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism	AcrySof® ReSTOR® Multifocal IOL Model SA60D3
Measure Participants	386	188
First Implanted Eye	1.04 0.3%	2.13 1.1%
Second Implanted Eye	0.52 0.1%	2.13 1.1%

4. Secondary Outcome

Title	Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5
Description	Visual disturbances/distortions were reported by the participant on the Assessment of Photic Phenomena and Lens EffectS (APPLES) questionnaire, a Patient Reported Outcome (PRO) questionnaire intended to evaluate 10 distinct visual phenomena associated with cataract extraction and IOL implantation. The first 20 questions addressed both the frequency and severity of the phenomena using a 4-point categorical scale ranging from "never" to "always" (frequency) or "none" to "severe" (severity). The final (21st) question indicated whether the participant answered the questions based on experiences with or without glasses. The participant completed the assessment as a retrospective analysis of the previous week. Rate is presented as the percentage of participants with severity score "severe" for the visual phenomenon.
Time Frame	Month 12 from second eye implantation

Outcome Measure Data

Analysis Population Description

This analysis population includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).

Arm/Group Title	ReSTOR Toric IOL	ReSTOR IOL
Arm/Group Description	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism	AcrySof® ReSTOR® Multifocal IOL Model SA60D3
Measure Participants	386	188
Blurred vision	0.8 0.2%	0.0 0%
Color distortion	0.0 0%	0.0 0%
Flat lines look curved	0.0 0%	0.0 0%
Straight lines look tilted	0.0 0%	0.0 0%
Double vision	0.8 0.2%	0.0 0%
Feeling sick due to visual distortion	0.0 0%	0.5 0.3%
Glare	3.5 0.9%	2.7 1.4%
Halos	7.5 1.9%	11.0 5.9%
Hazy vision	1.3 0.3%	0.5 0.3%
Starbursts	4.3 1.1%	8.8 4.7%

Adverse Events

Time Frame	This analysis group includes all participants with attempted IOL implantation (successful or aborted after contact with the eye).
Adverse Event Reporting Description	An Adverse Event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical sign, whether or not related to the investigational device. AEs were collected as solicited comments and as observations by the Investigator as outlined in the protocol. "At Risk" population for ocular AEs is included with unit of "eyes."
Arm/Group Title	ReSTOR Toric IOL		ReSTOR IOL
Arm/Group Description	AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism		AcrySof® ReSTOR® Multifocal IOL Model SA60D3
All Cause Mortality
	ReSTOR Toric IOL		ReSTOR IOL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	ReSTOR Toric IOL		ReSTOR IOL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	45/386 (11.7%)		21/188 (11.2%)
Cardiac disorders
Atrial fibrillation	1/386 (0.3%)		1/188 (0.5%)
Bradycardia	1/386 (0.3%)		0/188 (0%)
Cardiac arrest	0/386 (0%)		1/188 (0.5%)
Coronary artery disease	0/386 (0%)		2/188 (1.1%)
Eye disorders
Age-related macular degeneration (First Implanted Eye)	0/386 (0%)		1/188 (0.5%)
Cystoid macular oedema (First Implanted Eye)	1/386 (0.3%)		0/188 (0%)
Cystoid macular oedema (Second Implanted Eye)	3/383 (0.8%)		1/188 (0.5%)
Eye disorder (First Implanted Eye)	1/386 (0.3%)		0/188 (0%)
Eye disorder (Second Implanted Eye)	3/383 (0.8%)		0/188 (0%)
Glare (First Implanted Eye)	1/386 (0.3%)		0/188 (0%)
Glare (Second Implanted Eye)	1/383 (0.3%)		0/188 (0%)
Halo vision (First Implanted Eye)	1/386 (0.3%)		1/188 (0.5%)
Halo vision (Second Implanted Eye)	1/383 (0.3%)		2/188 (1.1%)
Iris atrophy (First Implanted Eye)	1/386 (0.3%)		0/188 (0%)
Iris atrophy (Second Implanted Eye)	1/383 (0.3%)		0/188 (0%)
Macular hole (Second Implanted Eye)	1/383 (0.3%)		0/188 (0%)
Macular oedema (Second Implanted Eye)	0/383 (0%)		1/188 (0.5%)
Photopsia (First Implanted Eye)	1/386 (0.3%)		0/188 (0%)
Photopsia (Second Implanted Eye)	1/383 (0.3%)		0/188 (0%)
Retinal detachment (First Implanted Eye)	1/386 (0.3%)		0/188 (0%)
Retinal detachment (Second Implanted Eye)	2/383 (0.5%)		1/188 (0.5%)
Retinal tear (Second Implanted Eye)	1/383 (0.3%)		0/188 (0%)
Vision blurred (First Implanted Eye)	1/386 (0.3%)		0/188 (0%)
Vision blurred (Second Implanted Eye)	0/383 (0%)		1/188 (0.5%)
Visual impairment (First Implanted Eye)	1/386 (0.3%)		1/188 (0.5%)
Visual impairment (Second Implanted Eye)	1/383 (0.3%)		1/188 (0.5%)
Vitreous prolapse (First Implanted Eye)	1/386 (0.3%)		0/188 (0%)
Gastrointestinal disorders
Colitis	1/386 (0.3%)		0/188 (0%)
Colitis ischaemic	0/386 (0%)		1/188 (0.5%)
Gastric ulcer haemorrhage	1/386 (0.3%)		0/188 (0%)
Gastrooesophageal reflux disease	1/386 (0.3%)		0/188 (0%)
Hiatus hernia	1/386 (0.3%)		0/188 (0%)
Peptic ulcer	2/386 (0.5%)		0/188 (0%)
General disorders
Death	1/386 (0.3%)		0/188 (0%)
Device dislocation (First Implanted Eye)	1/386 (0.3%)		0/188 (0%)
Hepatobiliary disorders
Bile duct stone	0/386 (0%)		1/188 (0.5%)
Cholecystitis acute	1/386 (0.3%)		0/188 (0%)
Cholecystitis chronic	1/386 (0.3%)		0/188 (0%)
Infections and infestations
Gastroenteritis viral	1/386 (0.3%)		0/188 (0%)
Pyothorax	1/386 (0.3%)		0/188 (0%)
Sepsis	1/386 (0.3%)		0/188 (0%)
Injury, poisoning and procedural complications
Cataract operation complication (First Implanted Eye)	2/386 (0.5%)		0/188 (0%)
Cataract operation complication (Second Implanted Eye)	1/383 (0.3%)		1/188 (0.5%)
Eye injury (Second Implanted Eye)	1/383 (0.3%)		0/188 (0%)
Fracture	0/386 (0%)		1/188 (0.5%)
Hip fracture	1/386 (0.3%)		1/188 (0.5%)
Surgical procedure repeated (First Implanted Eye)	3/386 (0.8%)		2/188 (1.1%)
Surgical procedure repeated (Second Implanted Eye)	1/383 (0.3%)		3/188 (1.6%)
Wound complication (Second Implanted Eye)	1/383 (0.3%)		1/188 (0.5%)
Metabolism and nutrition disorders
Dehydration	1/386 (0.3%)		0/188 (0%)
Musculoskeletal and connective tissue disorders
Arthritis	1/386 (0.3%)		0/188 (0%)
Intervertebral disc protrusion	1/386 (0.3%)		0/188 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer stage III	1/386 (0.3%)		0/188 (0%)
Colon cancer	1/386 (0.3%)		0/188 (0%)
Gastric neoplasm	1/386 (0.3%)		0/188 (0%)
Neuroendocrine carcinoma	1/386 (0.3%)		0/188 (0%)
Nervous system disorders
Dementia	1/386 (0.3%)		0/188 (0%)
Transient ischaemic attack	1/386 (0.3%)		0/188 (0%)
Psychiatric disorders
Mental status changes	1/386 (0.3%)		0/188 (0%)
Renal and urinary disorders
Renal failure acute	2/386 (0.5%)		0/188 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	0/386 (0%)		1/188 (0.5%)
Bronchial hyperreactivity	0/386 (0%)		1/188 (0.5%)
Hypoxia	1/386 (0.3%)		0/188 (0%)
Non-cardiogenic pulmonary oedema	0/386 (0%)		1/188 (0.5%)
Pulmonary embolism	1/386 (0.3%)		0/188 (0%)
Surgical and medical procedures
Cholecystectomy	0/386 (0%)		1/188 (0.5%)
Corneal operation (First Implanted Eye)	1/386 (0.3%)		1/188 (0.5%)
Corneal operation (Second Implanted Eye)	1/383 (0.3%)		1/188 (0.5%)
Eye laser surgery (First Implanted Eye)	1/386 (0.3%)		0/188 (0%)
Eye laser surgery (Second Implanted Eye)	3/383 (0.8%)		0/188 (0%)
Intraocular injection (First Implanted Eye)	0/386 (0%)		1/188 (0.5%)
Intraocular lens repositioning (First Implanted Eye)	4/386 (1%)		0/188 (0%)
Keratometry (First Implanted Eye)	1/386 (0.3%)		0/188 (0%)
Keratomileusis (First Implanted Eye)	1/386 (0.3%)		0/188 (0%)
Keratomileusis (Second Implanted Eye) A	1/383 (0.3%)		0/188 (0%)
Knee arthroplasty	1/386 (0.3%)		0/188 (0%)
Retinal operation (Second Implanted Eye)	1/383 (0.3%)		0/188 (0%)
Retinopexy (First Implanted Eye)	2/386 (0.5%)		0/188 (0%)
Retinopexy (Second Implanted Eye)	3/383 (0.8%)		1/188 (0.5%)
Rotator cuff repair	1/386 (0.3%)		0/188 (0%)
Suture insertion (Second Implanted Eye)	1/383 (0.3%)		1/188 (0.5%)
Vitrectomy (First Implanted Eye)	1/386 (0.3%)		0/188 (0%)
Vascular disorders
Aortic stenosis	1/386 (0.3%)		0/188 (0%)
Orthostatic hypotension	0/386 (0%)		1/188 (0.5%)
Other (Not Including Serious) Adverse Events
	ReSTOR Toric IOL		ReSTOR IOL
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	48/386 (12.4%)		28/188 (14.9%)
Eye disorders
Dry Eye (Second Implanted Eye)	8/383 (2.1%)		10/188 (5.3%)
Posterior capsule opacification (First Implanted Eye)	35/386 (9.1%)		17/188 (9%)
Posterior capsule opacification (Second Implanted Eye)	32/383 (8.4%)		19/188 (10.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.