Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL Model TFNT00
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Alcon Research
- Enrollment
- 167
- Primary Endpoint
- Mean Binocular Defocus Visual Acuity (VA)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
TFNT00
AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL, bilateral implantation
Intervention: AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL (Device)
Outcomes
Primary Outcomes
Mean Binocular Defocus Visual Acuity (VA)
Time Frame: Day 20-40 and Day 120-180 from second eye implantation
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 Outcomes
No secondary outcomes reported