Post-Market Clinical Investigation of the Clareon® IO

Phase 4

Completed

• Conditions: Cataract; 10047518

• Registration Number: NL-OMON46484
• Lead Sponsor: Alcon Laboratories

Brief Summary

Trial is onging in other countries

Detailed Description

Not available

Study Timeline

• Results First Posted: 2020-03-10
• Study Completion: 2021-10-20
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

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
2. Able to comprehend and willing to sign an IRB/IEC approved statement of informed consent and complete all required post-implantation visits
3. Planned small incision cataract removal surgery
4. Calculated lens power is within the available range (see Table 11-1 for the available range of lens powers for this study)
5. Subjects for whom postoperative emmetropia is planned (defined as 0.00± 0.50 D spherical equivalent) in both eyes
6. Preoperative BCDVA worse than 0.2 logMAR in at least one eye
Potential post-implantation visual acuity of 0.2 logMAR or better in both eyes based on Investigator expert medical opinion

Exclusion Criteria

1. Subjects who may reasonably be expected to require an ocular surgical treatment at any time during the study (other than Nd: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. Ocular conditions where the need for a large capsulotomy can be anticipated (eg, diabetics, retinal detachment in the fellow eye, peripheral retinal pathology)
10. Iris neovascularization
11. Glaucoma (uncontrolled or controlled with medication)
12. Current or recent use of an alpha-1-selective adrenoceptor blocking agent or an antagonist of alpha1A adrenoceptor (eg, Flomax (tamsulosin HCL), Hytrin, or Cardura) that in the opinion of the Investigator would potentially require mechanical or surgical manipulation to enlarge the pupil
13. Subjects with diagnosed degenerative eye disorders, such as but not limited to, pseudoexfoliation
14. 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
15. Optic nerve atrophy
16. Subjects who are expected to require retinal laser treatment
17. Subjects with diagnosed congenital ocular disorders, such as but not limited to, aniridia or microphthalmia
18. Pregnancy or lactation current or planned during the course of the study
19. Any subject currently participating in another investigational drug or device study that may confound the results of this investigation
20. Any other additional procedures during the cataract removal and IOL implant due to intraoperative complications that require further intervention (including but not limited to posterior rupture, with vitreous loss, zonular dehiscence that may make the IOL implant less stable
21. Uncontrolled intraocular pressure
22. Significant anterior chamber bleeding
23. Excessive iris mobility
24. Mechanical or surgical intervention required to manipulate the pupil
Note: Pupil size must be 4.5mm or larger just prior to implantation
25. Any capsulorhexis other than continuous curvilinear capsulorhexis (eg, no anterior radial inconsistencies in the capsulorhexis such as anterior capsular tears or any areas of *can-opener* capsulotomy)
26. Unrecognized (pre-existing but discovered during surgery) ocular conditions or complications in which the IOL positio

Study & Design

• Study Type: Interventional
• Study Design: Not specified