Clinical Investigation of the Visual Outcomes and Safety of a Trifocal Toric IOL in an Asian Population

Alcon

Status: Completed

Conditions: Corneal Astigmatism; Aphakia

Treatments: Device: ACRYSOF® IQ PanOptix® Toric Trifocal IOL; Procedure: Cataract surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT04528069

ILX140-P001

Details and patient eligibility

About

The purpose of this study is to evaluate the clinical performance of the ACRYSOF® IQ PanOptix® Toric Trifocal intraocular lens (IOL) when implanted in the eye following cataract removal in an Asian population.

Full description

Both eyes will be implanted with the PanOptix Toric Trifocal IOL. The eye with the highest astigmatism will be implanted first. The second eye will be implanted within 7-14 days of the first eye.

Subjects will attend a total of 10 scheduled visits as follows: 1 screening visit, 1 operative visit for each eye, 2 post-operative visits for each eye, and 3 postoperative visits where both eyes will be evaluated. The duration of participation for each subject will be approximately 8 months.

This study will be conducted in Australia.

Enrollment: 58 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Planned bilateral cataract removal followed by posterior chamber IOL implantation with PanOptix Toric (TFNT30, TFNT40, TFNT50, or TFNT60);
• Calculated target residual refractive error within ±0.50 diopter (D) of emmetropia within the commercially available IOL Power Range in both operative eyes;
• Preoperative regular corneal keratometric astigmatism with predicted residual refractive astigmatism ≤ 0.50 diopter (D) in both operative eyes;
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Preoperative irregular astigmatism;
• Clinically significant corneal abnormalities;
• Glaucoma;
• History of or current retinal disease; anterior or posterior segment inflammation;
• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

58 participants in 1 patient group

PanOptix Toric Trifocal IOL

Experimental group

Description:

PanOptix Toric Trifocal IOL implanted in the capsular bag in the posterior chamber following cataract surgery and intended for long-term use over the lifetime of the cataract patient. Both eyes will be implanted (bilateral implantation).

Treatment:

Procedure: Cataract surgery

Device: ACRYSOF® IQ PanOptix® Toric Trifocal IOL