ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01424189
Recruitment Status : Completed
First Posted : August 26, 2011
Results First Posted : March 6, 2017
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cataracts
Interventions Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
Device: AcrySof® ReSTOR® Multifocal IOL Model SA60D3
Enrollment 677
Recruitment Details Participants were recruited from 21 investigative sites located in the United States.
Pre-assignment Details 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
Hide 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
Reason Not Completed
Adverse Event             1             0
Lost to Follow-up             4             1
Withdrawal by Subject             4             4
Subject moved             1             0
Death             3             1
Arm/Group Title ReSTOR Toric IOL ReSTOR IOL Total
Hide 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 Number of Baseline Participants 386 188 574
Hide Baseline Analysis Population Description
This analysis population includes all participants with successful IOL implantation in at least 1 eye.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 386 participants 188 participants 574 participants
66.91  (9.20) 68.36  (8.13) 67.38  (8.88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 386 participants 188 participants 574 participants
Female
240
  62.2%
136
  72.3%
376
  65.5%
Male
146
  37.8%
52
  27.7%
198
  34.5%
1.Primary Outcome
Title Mean Monocular Uncorrected Distance Visual Acuity (UCDVA) at Fixed Distance at Visit 5
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
AcrySof® ReSTOR® Multifocal IOL Model SA60D3
Overall Number of Participants Analyzed 373 180
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
373 180
Least Squares Mean (Standard Error)
Unit of Measure: logMAR
0.126  (0.013) 0.125  (0.015)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ReSTOR Toric IOL, ReSTOR IOL
Comments [Not Specified]
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.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.001
Confidence Interval (1-Sided) 95%
0.030
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.013
Estimation Comments [Not Specified]
2.Primary Outcome
Title Mean Monocular Uncorrected Near Visual Acuity (UCNVA) at Fixed Distance at Visit 5
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
AcrySof® ReSTOR® Multifocal IOL Model SA60D3
Overall Number of Participants Analyzed 373 180
Mean (Standard Deviation)
Unit of Measure: logMAR
0.19  (0.015) 0.24  (0.017)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection ReSTOR Toric IOL, ReSTOR IOL
Comments [Not Specified]
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.
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.044
Confidence Interval (1-Sided) 95%
-0.017
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.015
Estimation Comments [Not Specified]
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
AcrySof® ReSTOR® Multifocal IOL Model SA60D3
Overall Number of Participants Analyzed 386 188
Measure Type: Number
Unit of Measure: percentage of participants
First Implanted Eye Number Analyzed 386 participants 188 participants
1.04 2.13
Second Implanted Eye Number Analyzed 383 participants 188 participants
0.52 2.13
4.Secondary Outcome
Title Rate of Severe Visual Disturbances/Distortions Reported on the Assessment of Photic Phenomena & Lens EffectS (APPLES) Questionnaire at Visit 5
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
AcrySof® ReSTOR® Multifocal IOL Model SA60D3
Overall Number of Participants Analyzed 386 188
Measure Type: Number
Unit of Measure: percentage of participants
Blurred vision Number Analyzed 372 participants 182 participants
0.8 0.0
Color distortion Number Analyzed 371 participants 182 participants
0.0 0.0
Flat lines look curved Number Analyzed 372 participants 182 participants
0.0 0.0
Straight lines look tilted Number Analyzed 372 participants 182 participants
0.0 0.0
Double vision Number Analyzed 372 participants 182 participants
0.8 0.0
Feeling sick due to visual distortion Number Analyzed 371 participants 182 participants
0.0 0.5
Glare Number Analyzed 372 participants 182 participants
3.5 2.7
Halos Number Analyzed 372 participants 182 participants
7.5 11.0
Hazy vision Number Analyzed 372 participants 182 participants
1.3 0.5
Starbursts Number Analyzed 372 participants 182 participants
4.3 8.8
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
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ReSTOR Toric IOL ReSTOR IOL
Affected / at Risk (%) Affected / at Risk (%)
Total   45/386 (11.66%)   21/188 (11.17%) 
Cardiac disorders     
Atrial fibrillation  1  1/386 (0.26%)  1/188 (0.53%) 
Bradycardia  1  1/386 (0.26%)  0/188 (0.00%) 
Cardiac arrest  1  0/386 (0.00%)  1/188 (0.53%) 
Coronary artery disease  1  0/386 (0.00%)  2/188 (1.06%) 
Eye disorders     
Age-related macular degeneration (First Implanted Eye)  1  0/386 (0.00%)  1/188 (0.53%) 
Cystoid macular oedema (First Implanted Eye)  1  1/386 (0.26%)  0/188 (0.00%) 
Cystoid macular oedema (Second Implanted Eye)  1  3/383 (0.78%)  1/188 (0.53%) 
Eye disorder (First Implanted Eye)  1  1/386 (0.26%)  0/188 (0.00%) 
Eye disorder (Second Implanted Eye)  1  3/383 (0.78%)  0/188 (0.00%) 
Glare (First Implanted Eye)  1  1/386 (0.26%)  0/188 (0.00%) 
Glare (Second Implanted Eye)  1  1/383 (0.26%)  0/188 (0.00%) 
Halo vision (First Implanted Eye)  1  1/386 (0.26%)  1/188 (0.53%) 
Halo vision (Second Implanted Eye)  1  1/383 (0.26%)  2/188 (1.06%) 
Iris atrophy (First Implanted Eye)  1  1/386 (0.26%)  0/188 (0.00%) 
Iris atrophy (Second Implanted Eye)  1  1/383 (0.26%)  0/188 (0.00%) 
Macular hole (Second Implanted Eye)  1  1/383 (0.26%)  0/188 (0.00%) 
Macular oedema (Second Implanted Eye)  1  0/383 (0.00%)  1/188 (0.53%) 
Photopsia (First Implanted Eye)  1  1/386 (0.26%)  0/188 (0.00%) 
Photopsia (Second Implanted Eye)  1  1/383 (0.26%)  0/188 (0.00%) 
Retinal detachment (First Implanted Eye)  1  1/386 (0.26%)  0/188 (0.00%) 
Retinal detachment (Second Implanted Eye)  1  2/383 (0.52%)  1/188 (0.53%) 
Retinal tear (Second Implanted Eye)  1  1/383 (0.26%)  0/188 (0.00%) 
Vision blurred (First Implanted Eye)  1  1/386 (0.26%)  0/188 (0.00%) 
Vision blurred (Second Implanted Eye)  1  0/383 (0.00%)  1/188 (0.53%) 
Visual impairment (First Implanted Eye)  1  1/386 (0.26%)  1/188 (0.53%) 
Visual impairment (Second Implanted Eye)  1  1/383 (0.26%)  1/188 (0.53%) 
Vitreous prolapse (First Implanted Eye)  1  1/386 (0.26%)  0/188 (0.00%) 
Gastrointestinal disorders     
Colitis  1  1/386 (0.26%)  0/188 (0.00%) 
Colitis ischaemic  1  0/386 (0.00%)  1/188 (0.53%) 
Gastric ulcer haemorrhage  1  1/386 (0.26%)  0/188 (0.00%) 
Gastrooesophageal reflux disease  1  1/386 (0.26%)  0/188 (0.00%) 
Hiatus hernia  1  1/386 (0.26%)  0/188 (0.00%) 
Peptic ulcer  1  2/386 (0.52%)  0/188 (0.00%) 
General disorders     
Death  1  1/386 (0.26%)  0/188 (0.00%) 
Device dislocation (First Implanted Eye)  1  1/386 (0.26%)  0/188 (0.00%) 
Hepatobiliary disorders     
Bile duct stone  1  0/386 (0.00%)  1/188 (0.53%) 
Cholecystitis acute  1  1/386 (0.26%)  0/188 (0.00%) 
Cholecystitis chronic  1  1/386 (0.26%)  0/188 (0.00%) 
Infections and infestations     
Gastroenteritis viral  1  1/386 (0.26%)  0/188 (0.00%) 
Pyothorax  1  1/386 (0.26%)  0/188 (0.00%) 
Sepsis  1  1/386 (0.26%)  0/188 (0.00%) 
Injury, poisoning and procedural complications     
Cataract operation complication (First Implanted Eye)  1  2/386 (0.52%)  0/188 (0.00%) 
Cataract operation complication (Second Implanted Eye)  1  1/383 (0.26%)  1/188 (0.53%) 
Eye injury (Second Implanted Eye)  1  1/383 (0.26%)  0/188 (0.00%) 
Fracture  1  0/386 (0.00%)  1/188 (0.53%) 
Hip fracture  1  1/386 (0.26%)  1/188 (0.53%) 
Surgical procedure repeated (First Implanted Eye)  1  3/386 (0.78%)  2/188 (1.06%) 
Surgical procedure repeated (Second Implanted Eye)  1  1/383 (0.26%)  3/188 (1.60%) 
Wound complication (Second Implanted Eye)  1  1/383 (0.26%)  1/188 (0.53%) 
Metabolism and nutrition disorders     
Dehydration  1  1/386 (0.26%)  0/188 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/386 (0.26%)  0/188 (0.00%) 
Intervertebral disc protrusion  1  1/386 (0.26%)  0/188 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer stage III  1  1/386 (0.26%)  0/188 (0.00%) 
Colon cancer  1  1/386 (0.26%)  0/188 (0.00%) 
Gastric neoplasm  1  1/386 (0.26%)  0/188 (0.00%) 
Neuroendocrine carcinoma  1  1/386 (0.26%)  0/188 (0.00%) 
Nervous system disorders     
Dementia  1  1/386 (0.26%)  0/188 (0.00%) 
Transient ischaemic attack  1  1/386 (0.26%)  0/188 (0.00%) 
Psychiatric disorders     
Mental status changes  1  1/386 (0.26%)  0/188 (0.00%) 
Renal and urinary disorders     
Renal failure acute  1  2/386 (0.52%)  0/188 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/386 (0.00%)  1/188 (0.53%) 
Bronchial hyperreactivity  1  0/386 (0.00%)  1/188 (0.53%) 
Hypoxia  1  1/386 (0.26%)  0/188 (0.00%) 
Non-cardiogenic pulmonary oedema  1  0/386 (0.00%)  1/188 (0.53%) 
Pulmonary embolism  1  1/386 (0.26%)  0/188 (0.00%) 
Surgical and medical procedures     
Cholecystectomy  1  0/386 (0.00%)  1/188 (0.53%) 
Corneal operation (First Implanted Eye)  1  1/386 (0.26%)  1/188 (0.53%) 
Corneal operation (Second Implanted Eye)  1  1/383 (0.26%)  1/188 (0.53%) 
Eye laser surgery (First Implanted Eye)  1  1/386 (0.26%)  0/188 (0.00%) 
Eye laser surgery (Second Implanted Eye)  1  3/383 (0.78%)  0/188 (0.00%) 
Intraocular injection (First Implanted Eye)  1  0/386 (0.00%)  1/188 (0.53%) 
Intraocular lens repositioning (First Implanted Eye)  1  4/386 (1.04%)  0/188 (0.00%) 
Keratometry (First Implanted Eye)  1  1/386 (0.26%)  0/188 (0.00%) 
Keratomileusis (First Implanted Eye)  1  1/386 (0.26%)  0/188 (0.00%) 
Keratomileusis (Second Implanted Eye) A  1  1/383 (0.26%)  0/188 (0.00%) 
Knee arthroplasty  1  1/386 (0.26%)  0/188 (0.00%) 
Retinal operation (Second Implanted Eye)  1  1/383 (0.26%)  0/188 (0.00%) 
Retinopexy (First Implanted Eye)  1  2/386 (0.52%)  0/188 (0.00%) 
Retinopexy (Second Implanted Eye)  1  3/383 (0.78%)  1/188 (0.53%) 
Rotator cuff repair  1  1/386 (0.26%)  0/188 (0.00%) 
Suture insertion (Second Implanted Eye)  1  1/383 (0.26%)  1/188 (0.53%) 
Vitrectomy (First Implanted Eye)  1  1/386 (0.26%)  0/188 (0.00%) 
Vascular disorders     
Aortic stenosis  1  1/386 (0.26%)  0/188 (0.00%) 
Orthostatic hypotension  1  0/386 (0.00%)  1/188 (0.53%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ReSTOR Toric IOL ReSTOR IOL
Affected / at Risk (%) Affected / at Risk (%)
Total   48/386 (12.44%)   28/188 (14.89%) 
Eye disorders     
Dry Eye (Second Implanted Eye)  1  8/383 (2.09%)  10/188 (5.32%) 
Posterior capsule opacification (First Implanted Eye)  1  35/386 (9.07%)  17/188 (9.04%) 
Posterior capsule opacification (Second Implanted Eye)  1  32/383 (8.36%)  19/188 (10.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (13.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Name/Title: Expert Clinical Project Lead, GCRA, Surgical
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01424189     History of Changes
Other Study ID Numbers: C-09-036
First Submitted: August 25, 2011
First Posted: August 26, 2011
Results First Submitted: January 13, 2017
Results First Posted: March 6, 2017
Last Update Posted: June 29, 2018