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RECRUITING
NCT07232615
NA

A Planned Study at Multiple Sites is Being Done to Compare the Results of Two Types of Trifocal Toric Intraocular Lenses Used in Cataract Surgery

Sponsor: Biotech Healthcare Holding Gmbh

View on ClinicalTrials.gov

Summary

To evaluate the clinical outcomes and patient satisfaction of two commercially available trifocal toric intraocular lenses Primary Objective: To compare the distance-corrected intermediate visual acuity between the two trifocal toric intraocular lenses. Secondary Objectives: To assess and compare the safety of two trifocal toric intraocular lenses.

Official title: A Prospective, Multicenter Clinical Study Comparing Outcomes of Two Trifocal Toric Intraocular Lens

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

138

Start Date

2021-11-22

Completion Date

2027-02

Last Updated

2025-11-18

Healthy Volunteers

No

Interventions

DEVICE

Optiflex TRIO Intraocular Lens

The patients will be implanted with Optiflex TRIO IOL at this arm based on randomization. Trifocal lenses are part of the premium range of refractive-diffractive trifocal IOLs with advanced aspheric optics for excellent visual outcomes. They are single piece, posterior chamber foldable intraocular lenses. The optic is refractive-diffractive trifocal Toric with the anterior surface being aspheric and the posterior surface with a square edge design. The lens is designed to provide all near, distance and intermediate vision and thereby reduce spectacle dependency. Toric version of trifocal intraocular lens is intended to correct astigmatism

DEVICE

AcrySof® IQ PanOptix®

The patients will be implanted with AcrySof® IQ PanOptix® at this arm based on randomization. Trifocal lenses are part of the premium range of refractive-diffractive trifocal IOLs with advanced aspheric optics for excellent visual outcomes. They are single piece, posterior chamber foldable intraocular lenses. The optic is diffractive trifocal with the anterior surface being aspheric and the posterior surface with a toric component. The lens is designed to provide all near, distance and intermediate vision and thereby reduce spectacle dependency. Toric version of trifocal intraocular lens is intended to correct astigmatism.

Locations (6)

Internationale Innovative Ophthalmochirurgie GbR

Düsseldorf, North Rhine-Westphalia, Germany

Augentagesklinik

Greven, North Rhine-Westphalia, Germany

Augentagesklinik

Rheine, North Rhine-Westphalia, Germany

Netradhama Superspeciality Eye Hospital

Bangalore, Karnatak, India

Dr. Agarwal Eye Hospital

Chennai, Tamil Nadu, India

Hospital Arruzafa

Córdoba, Córdoba, Spain