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Retrospective / Prospective Clinical Study of AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lenses

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ClinicalTrials.gov Identifier: NCT02176343
Recruitment Status : Completed
First Posted : June 27, 2014
Results First Posted : June 29, 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: Other
Conditions Cataract
Presbyopia
Corneal Astigmatism
Intervention Device: AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
Enrollment 37
Recruitment Details Subjects were recruited from 4 study centers located in Australia.
Pre-assignment Details Of the 37 enrolled, 6 subjects were exited as screen failures and were ineligible to participate in the study. This reporting group includes all subjects who provided informed consent and were determined to be eligible based upon the inclusion and exclusion criteria (As Treated) (31).
Arm/Group Title ReSTOR Toric +2.5
Hide Arm/Group Description AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric Intraocular Lens (IOL)
Period Title: Overall Study
Started 31
Completed 31
Not Completed 0
Arm/Group Title ReSTOR Toric +2.5
Hide Arm/Group Description AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
As Treated
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants
69.2  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
17
  54.8%
Male
14
  45.2%
1.Primary Outcome
Title Mean Percent Reduction in Cylinder
Hide Description Manifest refraction cylinder was measured monocularly (each eye separately) with best correction (phoropter or trial lenses) under photopic (well-lit) lighting conditions using a 100% contrast ETDRS chart at 4 meters (m) from the subject. Percent reduction in cylinder was calculated as the difference between the postoperative magnitude of manifest refractive cylinder and the preoperative magnitude of keratometric cylinder divided by the intended reduction in cylinder [defined as the difference between the intended (from toric calculator) magnitude of the postoperative manifest refractive cylinder and the preoperative keratometric cylinder], multiplied by 100%. One eye (primary eye) contributed to the analysis.
Time Frame Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
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Hide Analysis Population Description
As Treated
Arm/Group Title ReSTOR Toric +2.5
Hide Arm/Group Description:
AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: percent change
60.94  (38.17)
2.Primary Outcome
Title Percentage of Subjects With Manifest Refraction Cylinder ≤ 0.50 D
Hide Description Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.
Time Frame Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Hide Outcome Measure Data
Hide Analysis Population Description
As Treated
Arm/Group Title ReSTOR Toric +2.5
Hide Arm/Group Description:
AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
Overall Number of Participants Analyzed 31
Measure Type: Number
Unit of Measure: percentage of subjects
67.7
3.Primary Outcome
Title Percentage of Subjects (With Preoperative Astigmatism > 1.00 D) With Manifest Refraction Cylinder ≤ 1.00 D
Hide Description Manifest refraction cylinder was measured monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m from the subject. One eye (primary eye) contributed to the analysis.
Time Frame Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis population includes all subjects who provided informed consent and were determined eligible based upon the inclusion and exclusion criteria, having preoperative astigmatism > 1.00 D.
Arm/Group Title ReSTOR Toric +2.5
Hide Arm/Group Description:
AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: percentage of subjects
100.0
4.Primary Outcome
Title Mean Uncorrected Distance Visual Acuity
Hide Description Visual Acuity (VA) was tested monocularly without visual correction under photopic (well-lit) conditions using a 100% contrast ETDRS chart positioned 4 m from the subject. A +0.25 D spherical power additional lens was used 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. One eye (primary eye) contributed to the analysis.
Time Frame Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Hide Outcome Measure Data
Hide Analysis Population Description
As Treated
Arm/Group Title ReSTOR Toric +2.5
Hide Arm/Group Description:
AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: logMAR
0.07  (0.12)
5.Primary Outcome
Title Mean Uncorrected Near Visual Acuity
Hide Description VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 40 cm on the nearpoint rod of the phoropter. 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. One eye (primary eye) contributed to the analysis.
Time Frame Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Hide Outcome Measure Data
Hide Analysis Population Description
As Treated
Arm/Group Title ReSTOR Toric +2.5
Hide Arm/Group Description:
AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: logMAR
0.38  (0.16)
6.Primary Outcome
Title Mean Uncorrected Intermediate Visual Acuity
Hide Description VA was tested monocularly without visual correction under photopic lighting conditions using a 100% contrast near ETDRS chart set at 53 cm on the nearpoint rod of the phoropter. 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. One eye (primary eye) contributed to the analysis.
Time Frame Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Hide Outcome Measure Data
Hide Analysis Population Description
As Treated
Arm/Group Title ReSTOR Toric +2.5
Hide Arm/Group Description:
AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: logMAR
0.25  (0.16)
7.Primary Outcome
Title Mean Best Corrected Distance Visual Acuity (BCDVA)
Hide Description VA was tested monocularly with best correction under photopic lighting conditions using a 100% contrast ETDRS chart at 4 m away from the subject. 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. One eye (primary eye) contributed to the analysis.
Time Frame Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Hide Outcome Measure Data
Hide Analysis Population Description
As Treated
Arm/Group Title ReSTOR Toric +2.5
Hide Arm/Group Description:
AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: logMAR
-0.03  (0.08)
8.Primary Outcome
Title Mean IOL Rotation
Hide Description Lens axis orientation (position of the lens within the capsular bag) as indicated by indentations on the IOL was assessed during slit lamp examination. IOL rotation (the difference between the achieved lens axis orientation at visit and achieved axis placement at surgery) was measured in degrees. One eye (primary eye) contributed to the analysis.
Time Frame Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Hide Outcome Measure Data
Hide Analysis Population Description
As Treated
Arm/Group Title ReSTOR Toric +2.5
Hide Arm/Group Description:
AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: degrees
3.74  (3.86)
Time Frame The time period of collection of AEs was preoperative to postoperative visit 3-14 months after IOL implantation. This analysis population includes all subjects who provided informed consent and were determined eligible based upon inclusion and exclusion criteria (As Treated).
Adverse Event Reporting Description An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the investigational product. AEs were obtained as solicited and volunteered comments from subjects and as observations by the study Investigator as outlined in the study protocol.
 
Arm/Group Title ReSTOR Toric +2.5
Hide Arm/Group Description All subjects implanted with AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL
All-Cause Mortality
ReSTOR Toric +2.5
Affected / at Risk (%)
Total   0/31 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
ReSTOR Toric +2.5
Affected / at Risk (%)
Total   3/31 (9.68%) 
Eye disorders   
Macular oedema  1  1/31 (3.23%) 
Retinal vein occlusion  1  1/31 (3.23%) 
Strabismus  1  1/31 (3.23%) 
Infections and infestations   
Staphylococcal infection  1  1/31 (3.23%) 
Surgical and medical procedures   
Intra-ocular injection  1  1/31 (3.23%) 
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
ReSTOR Toric +2.5
Affected / at Risk (%)
Total   4/31 (12.90%) 
Eye disorders   
Photopsia  1  2/31 (6.45%) 
Surgical and medical procedures   
Knee arthroplasty  1  2/31 (6.45%) 
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
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: Clinical Project Lead, GCRA, Surgical
Organization: Alcon Research, Ltd.
Phone: 1-888-451-3937
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02176343     History of Changes
Other Study ID Numbers: C-14-005
First Submitted: June 25, 2014
First Posted: June 27, 2014
Results First Submitted: March 29, 2017
Results First Posted: June 29, 2017
Last Update Posted: July 2, 2018