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AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL) Clinical Study in Japan

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ClinicalTrials.gov Identifier: NCT01323777
Recruitment Status : Completed
First Posted : March 28, 2011
Results First Posted : March 6, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cataracts
Intervention Device: AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
Enrollment 65
Recruitment Details Subjects were recruited from 2 study sites located in Japan.
Pre-assignment Details This reporting group includes all implanted subjects (65).
Arm/Group Title ReSTOR +3.0
Hide Arm/Group Description AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
Period Title: Overall Study
Started 65
Completed 65
Not Completed 0
Arm/Group Title ReSTOR +3.0
Hide Arm/Group Description AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
Overall Number of Baseline Participants 65
Hide Baseline Analysis Population Description
This analysis population includes all implanted subjects.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants
66.4  (9.9)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 65 participants
<60 years 12
60-69 years 24
70-79 years 25
≥ 80 years 4
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants
Female
50
  76.9%
Male
15
  23.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 65 participants
65
1.Primary Outcome
Title Monocular Uncorrected Distance Decimal Visual Acuity
Hide Description Visual acuity (VA) was tested monocularly (each eye separately) unaided at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Time Frame Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all implanted subjects.
Arm/Group Title Day 1-2 Day 7-14 Day 30-60 Day 120-180 Day 330-420
Hide Arm/Group Description:
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
Overall Number of Participants Analyzed 65 65 65 65 65
Measure Type: Number
Unit of Measure: participants
Primary eye worse than 0.5 decimal 3 3 1 0 1
Primary eye 0.5 to less than 0.7 decimal 12 4 6 3 5
Primary eye 0.7 to less than 1.0 decimal 29 27 30 27 28
Primary eye 1.0 decimal or better 21 31 28 35 31
Secondary eye worse than 0.5 decimal 5 1 3 1 0
Secondary eye 0.5 to less than 0.7 decimal 14 7 2 6 6
Secondary eye 0.7 to less than 1.0 decimal 21 22 28 28 27
Secondary eye 1.0 decimal or better 25 35 32 30 32
2.Primary Outcome
Title Monocular Uncorrected Near Decimal VA
Hide Description VA was tested monocularly unaided at a distance of 40 centimeters (cm) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity.
Time Frame Day 30-60, Day 120-180, Day 330-420
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all implanted subjects.
Arm/Group Title Day 30-60 Day 120-180 Day 330-420
Hide Arm/Group Description:
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
Overall Number of Participants Analyzed 65 65 65
Measure Type: Number
Unit of Measure: participants
Primary eye worse than 0.4 decimal 1 0 1
Primary eye 0.4 decimal or better 64 65 64
Secondary eye worse than 0.4 decimal 1 1 0
Secondary eye 0.4 decimal or better 64 64 65
Time Frame This reporting group includes all implanted subjects.
Adverse Event Reporting Description An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user or other persons regardless of whether or not the event has a causal relationship with the medical device(s) or test procedure(s) in the study. AEs were collected as solicited comments from the subject and as observations by the study Investigator as outlined in the protocol.
 
Arm/Group Title ReSTOR +3.0
Hide Arm/Group Description AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
All-Cause Mortality
ReSTOR +3.0
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ReSTOR +3.0
Affected / at Risk (%)
Total   8/65 (12.31%) 
Cardiac disorders   
Atrial fibrillation paroxysmal  1  1/65 (1.54%) 
Infections and infestations   
Endophthalmitis (Primary Eye)  1  1/65 (1.54%) 
Injury, poisoning and procedural complications   
Eighth rib fracture  1  1/65 (1.54%) 
Spinal compression fracture  1  1/65 (1.54%) 
Musculoskeletal and connective tissue disorders   
Gonarthrosis  1  1/65 (1.54%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Carcinoma hepatocellular  1  1/65 (1.54%) 
Oropharyngeal cancer  1  1/65 (1.54%) 
Nervous system disorders   
Carotid artery stenosis  1  1/65 (1.54%) 
Cerebral infarction  1  1/65 (1.54%) 
Surgical and medical procedures   
Secondary surgical intervention (Primary Eye)  1  2/65 (3.08%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ReSTOR +3.0
Affected / at Risk (%)
Total   0/65 (0.00%) 
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: Group Manager, Surgical
Organization: Alcon Japan, Ltd.
Phone: 1-888-451-3937
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01323777     History of Changes
Other Study ID Numbers: J-10-050
First Submitted: March 24, 2011
First Posted: March 28, 2011
Results First Submitted: January 13, 2017
Results First Posted: March 6, 2017
Last Update Posted: July 2, 2018