Back to resultsInvestigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00
Primary Purpose
Cataract
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision;
- Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
- Clear intraocular media other than cataract in both eyes;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema;
- Ocular trauma, corneal transplant, retinal conditions, degenerative eye disorders, or color vision deficiencies;
- Glaucoma (uncontrolled or controlled with medication) or ocular hypertension;
- Pregnant or lactating;
- Expected to require ocular surgical or retinal laser treatment;
- Other protocol-specified exclusion criteria may apply.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TFNT00
Arm Description
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
Outcomes
Primary Outcome Measures
Mean Binocular Defocus Visual Acuity (VA)
Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best spectacle correction at a distance of 4 meters. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. The defocus VA summaries are based on the number of subjects evaluable for Best-Case Analysis Set and have data available at the corresponding visit. No formal statistical hypothesis testing was planned.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02529488
Brief Title
Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00
Official Title
Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL Model TFNT00
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 7, 2015 (Actual)
Primary Completion Date
November 30, 2016 (Actual)
Study Completion Date
June 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate visual outcomes and assess safety at 12 months (330-420 days) post bilateral implantation of the AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL.
Detailed Description
This study will be conducted in regions where the test article is approved at the time of study start.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
167 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TFNT00
Arm Type
Experimental
Arm Description
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
Intervention Type
Device
Intervention Name(s)
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL
Other Intervention Name(s)
Model TFNT00
Intervention Description
Multifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient
Primary Outcome Measure Information:
Title
Mean Binocular Defocus Visual Acuity (VA)
Description
Defocus VA (an indicator of the expected range of vision with a presbyopia-correcting IOL) was tested binocularly (both eyes together) with the subject's best spectacle correction at a distance of 4 meters. Lenses of different spherical powers were placed in front of the eyes to produce varying levels of defocus. The VA at each spherical power was measured in logarithm of the minimum angle of resolution (logMAR), with 0.1 logMAR increment corresponding to 5 letters, or 1 line, on an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. A lower numeric value represents better visual acuity. The defocus VA summaries are based on the number of subjects evaluable for Best-Case Analysis Set and have data available at the corresponding visit. No formal statistical hypothesis testing was planned.
Time Frame
Day 20-40 and Day 120-180 from second eye implantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of bilateral cataracts with planned cataract removal by phacoemulsification with a clear cornea incision;
Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;
Clear intraocular media other than cataract in both eyes;
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
Clinically significant corneal abnormalities including corneal dystrophy, inflammation or edema;
Ocular trauma, corneal transplant, retinal conditions, degenerative eye disorders, or color vision deficiencies;
Glaucoma (uncontrolled or controlled with medication) or ocular hypertension;
Pregnant or lactating;
Expected to require ocular surgical or retinal laser treatment;
Other protocol-specified exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sr Clinical Manager, Cataract
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00
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