NL-OMON43373
Completed
Phase 4
Clinical Investigation of Visual Function After Bilateral Implantation of Two Presbyopia-Correcting Trifocal IOLs. - Investigation of Two Presbyopia-Correcting Trifocal IOLs.
Alcon Laboratories0 sites10 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Presbyopia
- Sponsor
- Alcon Laboratories
- Enrollment
- 10
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adults, 22 years of age or older at the time of surgery, of either gender or any race, diagnosed with bilateral cataracts with planned clear cornea cataract removal.
- •2\. Able to comprehend and willing to sign informed consent and complete all required postoperative follow\-up procedures.
- •3\. Calculated lens power between 13\.0 and 30\.0 D.
- •4\. Preoperative BCDVA worse than 0\.20 logMAR (ie, 0\.22 logMAR or worse) in at least one eye.
- •5\. Potential postoperative BCDVA of 0\.20 logMAR or better in both eyes based on Investigator expert medical opinion.
- •Note: Subjects with any pathology that could reduce visual potential should not be enrolled in this trial.
- •6\. Preoperative regular corneal astigmatism of \< 1\.00 D, in both eyes.
- •7\. Clear intraocular media other than cataract in both eyes.
Exclusion Criteria
- •Prior operation, ocular criteria must be met in both eyes.
- •1\. Subjects who may reasonably be expected to require an ocular surgical treatment at any time during the study (other than YAG capsulotomy).
- •2\. Previous refractive surgery or planned refractive surgery procedures throughout the entire duration of the subjects\* participation in the clinical study (including, but not limited to LASIK, astigmatic keratotomy and limbal relaxing incisions);
- •3\. Clinically significant corneal abnormalities including corneal dystrophy (eg, epithelial, stromal, or endothelial dystrophy), inflammation or edema per the Investigator\*s expert medical opinion.
- •Note: conditions including, but not limited to: keratitis, keratoconjunctivitis, keratouveitis, keratopathy, or keratectasia should be excluded.
- •4\. Amblyopia.
- •5\. Previous corneal transplant.
- •6\. Extremely shallow anterior chamber (\* 2\.5 mm), not due to swollen cataract.
- •7\. Any recurrent severe anterior or posterior segment inflammation of any etiology, and/or history of any disease producing an intraocular inflammatory reaction.
- •8\. Rubella, congenital, traumatic, or complicated cataracts.
Outcomes
Primary Outcomes
Not specified
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