Clinical Investigation of Visual Function After Bilateral Implantation of Two Presbyopia-Correcting Trifocal IOLs.

Phase 4

Completed

• Conditions: Presbyopia; 10047518

• Registration Number: NL-OMON43373
• Lead Sponsor: Alcon Laboratories

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

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.
9. Situations where the need for a large capsulotomy can be anticipated (eg, diabetics, retinal detachment in the fellow eye, peripheral retinal pathology, etc.).
10. Iris neovascularization.
11. Glaucoma (uncontrolled or controlled with medication).
12. Subjects with diagnosed degenerative eye disorders.
13. History of or current retinal conditions or predisposition to retinal conditions, previous history of, or a predisposition to, retinal detachment or presence of diabetic retinopathy that the Investigator judges could confound outcomes.
Note: Including but not limited to background diabetic retinopathy, diabetic macular edema or proliferative diabetic retinopathy, macular degeneration.
14. Optic nerve atrophy.
15. Subjects who are expected to require retinal laser treatment.
16. Known color vision deficiencies.
17. Pregnancy or lactation current or planned during the course of the study.
18. Any subject currently participating in another investigational drug or device study that may confound the results of this investigation.;During Surgery.
19. Any other additional procedures during the phacoemulsification and IOL implant due to intraoperative complications that require further intervention (including but not limited to posterior capture rupture, vitreous loss, zonular dehiscence that may make the IOL implant less stable, etc.).
20. Uncontrolled intraocular pressure.
21. Significant anterior chamber bleeding.
22. Excessive iris mobility.
23. Mechanical or surgical manipulation required to enlarge the pupil prior to or at IOL implantation (pupil size must be at least 4.5 mm or larger just prior to implantation).
24. Capsulorhexis tears or any areas of *can-opener* capsulotomy.
25. Unrecognized (pre-existing but discovered during surgery) ocular conditions or complications in which the IOL stability could be compromised, including zonular weakness.
26. Zonular or Capsule rupture.
27. Intended IOL haptic placement other than bag-bag.

Study & Design

• Study Type: Interventional
• Study Design: Not specified