N/A N=32 Treatment

Clinical Investigation of an AcrySof IQ PanOptix Toric Intraocular Lens

Aphakia · Corneal Astigmatism

Bottom Line

View on ClinicalTrials.gov: NCT04542525 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2022

Primary outcome: Primary: Percentage of Eyes With ≤ 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60) — 90.2 percentage of eyes — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ACRYSOF IQ PanOptix Toric Trifocal IOL (Device); Cataract surgery (Procedure)
Age: Adult, Older Adult · 20+ yrs
Sex: All
Sponsor: Alcon Research
Primary completion: Aug 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Eyes With ≤ 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)	90.2	<0.0001 sig
SECONDARY Percentage of Eyes With ≤ 0.5 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)	100	—
SECONDARY Average Absolute Manifest Refractive Cylinder at Visit 3/3A (Day 30-60)	0.055	—

Summary

The purpose of this study is to evaluate the effectiveness and safety of the TFNT20 low cylinder power intraocular lens when implanted in the eye to replace the natural lens following cataract removal.

Eligibility Criteria

Key Inclusion Criteria

Eligible to be implanted with AcrySof IQ PanOptix Toric Intraocular Lens Model TFNT20 in at least one eye.
Potential postoperative Best Corrected Distance Visual Acuity (BCDVA) of 0.5 decimal or better.
Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria

Irregular corneal astigmatism.
History of anterior segment, posterior segment, or 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 laser assisted in situ keratomileusis (LASIK).
Other protocol-defined exclusion criteria may apply.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04542525). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.