N/A
N=98
Corrected VA With Long-Term Follow-Up After AcrySof® Intraocular Lens (IOL) Implantation
Pseudophakia
Bottom Line
View on ClinicalTrials.gov: NCT02450799 ↗Enrolled (actual)
98
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit — -0.06; -0.09; -0.07; 0.01 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acrylic IOL (Device); Silicone IOL (Device); PMMA IOL (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Alcon, a Novartis Company
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit |
-0.06; -0.09; -0.07; 0.01; 0.04; -0.01 | — |
Summary
The purpose of this study is to compare the long-term visual acuity (VA) with an acrylic IOL to a silicone or polymethylmethacrylate (PMMA) IOL in cataract patients. This study will take place in Japan.
Eligibility Criteria
Inclusion Criteria
- Willing to provide voluntary consent and able to comprehend and sign the informed consent form;
- Pseudophakic patients implanted with an Acrylic (AcrySof®), PMMA or silicone IOL from 1994 to 2000;
- Clear intraocular media in study eye;
- Best-corrected visual acuity (decimal) within 3 months post-implantation of 0.8 (decimal VA chart) or more in study eye;
- No ocular or systemic condition which may affect visual acuity in study eye;
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Complications that may impact visual acuity in study eye at the time of the prospective visit, such as glaucoma, diabetic retinitis, ocular inflammatory disease, retinal detachment, and others as specified in the protocol;
- Previous refractive surgery in study eye;
- Previous IOL exchange in study eye;
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02450799). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.