NCT02176343|CompletedResultsFDA Device
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Sponsor study identifier
interventional
37
0 countries
N/A
Study Start
July 21, 2014
Actual (reported)Primary Completion
August 22, 2014
Actual (reported)Study Completion
August 22, 2014
Actual (reported)The purpose of this study is to characterize the safety and effectiveness of the ACRYSOF IQ ReSTOR +2.5 diopter (D) Multifocal Toric Intraocular Lens (IOL) in subjects at least 3 months and no more than 14 months after IOL implantation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 22, 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 25, 2014
Actual (reported)June 27, 2014
Actual (reported)July 21, 2014
Actual (reported)August 22, 2014
Actual (reported)August 22, 2014
Actual (reported)June 29, 2017
Actual (reported)Mean Percent Reduction in Cylinder
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.
Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Percentage of Subjects With Manifest Refraction Cylinder ≤ 0.50 D
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.
Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Percentage of Subjects (With Preoperative Astigmatism > 1.00 D) With Manifest Refraction Cylinder ≤ 1.00 D
AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL previously implanted during cataract surgery
Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Clinical Manager, GCRA, Surgical
Alcon Research
37 participants (actual enrollment reported by the registry).
First Submitted
June 25, 2014
First Posted
June 27, 2014
Study Start
July 21, 2014
Actual (reported)Primary Completion
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.
Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Mean Uncorrected Distance Visual Acuity
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.
Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Mean Uncorrected Near Visual Acuity
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.
Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Mean Uncorrected Intermediate Visual Acuity
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.
Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Mean Best Corrected Distance Visual Acuity (BCDVA)
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.
Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Mean IOL Rotation
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.
Preoperative and Postoperative Visit (3 to 14 months after IOL implantation)
Contact the study team to confirm eligibility.
August 22, 2014
Actual (reported)Study Completion
August 22, 2014
Actual (reported)Last Updated
July 2, 2018
Results First Posted
June 29, 2017
Record last verified: 2017-05
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Source: ClinicalTrials.gov.
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