Clinical Investigation of an AcrySof IQ PanOptix Toric Intraocular Lens

Phase 3

Completed

• Conditions: Cataract; D002386

• Registration Number: JPRN-jRCT2032200147
• Lead Sponsor: Bissen-Miyajima Hiroko

Brief Summary

The primary endpoint of this study was the percentage of eyes with <=0.25 D cylinder power at 1-2 months postoperative. The percentage of eyes with <=0.25 D of absolute refractive cylinder was 90.2% at Visit 3/3A (Day 30-60), showing a significant difference from the historical threshold calculated based on the past studies using non-toric IOLs. No AEs related to the study device were reported. No subjects discontinued the study due to AEs, and there were no safety concerns of the study device.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-12
• Study Completion: 2021-08-10
• Last Update Posted: 2023-10-17

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Eligible to be implanted with AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20 in at least one eye as determined by a new Alcon Toric calculator.
- Planned postoperative emmetropia (spherical equivalent +-0.50 D).
- Other protocol-specified inclusion criteria may apply.

Exclusion Criteria

- Irregular corneal astigmatism.
- History of anterior segment (corneal, anterior chamber, sulcus) or posterior segment (uveal, vitreo-retinal) pathology.
- Glaucoma; ocular hypertension; diabetic retinopathy; any optic nerve pathology.
- History of previous intraocular or corneal (refractive or trauma related) surgery.
- Any other planned ocular surgical procedures including but not limited to limbal relaxing incision (LRI)/Astigmatic Keratotomy and LASIK.
- Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: Interventional
• Study Design: Not specified