Investigation of the AcrySof® IQ PanOptix* Presbyopia Correcting IOL Model TFNT00

Phase 4

Completed

• Conditions: Presbyopia; 10047518

• Registration Number: NL-OMON44109
• 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 cataract removal by phacoemulsification with a clear cornea incision;;2. Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures;;3. Calculated lens power within the available range;;4. Preoperative BCDVA worse than 0.20 logMAR (ie, 0.22 logMAR or worse) in both eyes;;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;1. 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;;2. Previous corneal transplant;;3. Ocular trauma, previous refractive surgery or 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);;4. 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);;5. Ambylopia;;6. Rubella, congenital, traumatic, or complicated cataracts;;7. Extremely shallow anterior chamber (* 2.5 mm), not due to swollen cataract;;8. Any current anterior or posterior segment inflammation of any etiology, and /or history of any disease producing an intraocular inflammatory reaction;;9. Iris neovascularization;;10. Glaucoma (uncontrolled or controlled with medication) or ocular hypertension;;11. Optic nerve atrophy;;12. Subjects with diagnosed degenerative eye disorders;;13. Known color vision deficiencies;;14. Pregnancy or lactation;;15. Any subject currently participating in another investigational drug or device study that may confound the results of this investigation;;16. Subjects who may reasonably be expected to require an ocular surgical treatment at any time during the study (other than YAG capsulotomy);;17. Situations where the need for a large capsulotomy can be anticipated (eg, diabetics, retinal detachment in the fellow eye, peripheral retinal pathology, etc.);;18. Subjects who are expected to require retinal laser treatment.;During Surgery;1. 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.);;2. Zonular or Capsule rupture;;3. Excessive iris mobility;;4. 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);;5. Significant anterior chamber bleeding;;6. Uncontrolled intraocular pressure;;7. Unrecognized (pre-existing but discovered during surgery ocular conditions or complications in which the IOL stability could be compromised, including zonular weakness;;8. Any incision site other than temporal;;9. Bag-sulcus, sulcus-sulcus or unknown placement of the haptics;;10. Capsulorhexis tears or any areas of *can-opener* capsulotomy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To assess the visual outcomes and safety over a period of 12 months (330 - 420<br /><br>days)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Not applicable</p><br>