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

NCT07232615 · tracked via the Priya Life Science Spain tracker

Sponsor

Biotech Healthcare Holding Gmbh

Phase

Not applicable

Started

2021-11-22

Last updated

2025-11-18

Condition(s) studied

Presbyopia CorrectionAstigmatismCataract

Investigational drug(s) / intervention(s)

Optiflex TRIO Intraocular LensAcrySof® IQ PanOptix®

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

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.

Study 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.

Eligibility

Sex

ALL

Min age

21 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Age of patient \>21 Years 2. Patient diagnosed with cataract. 3. Patient must have preoperative regular corneal astigmatism between 0.75 to 4.5 D as per corneal topography or keratometry 4. Calculated IOL power is within the range of investigational IOLs. 5. Patient willing to sign inform consent form. 6. Clear intraocular media other than cataract. 7. Female participants of childbearing potential must be willing to ensure that they use effective contraception during the study. Exclusion Criteria: 1. Previous intraocular or corneal surgery. 2. Traumatic cataract 3. Pregnancy (as stated by patient) or lactation. 4. Concurrent participation in another drug or device investigation. 5. Irregular astigmatism. 6. Patient receiving chlorquine treatment. 7. Subjects with any systemic disease that could increase operative risk or confound the outcome. 8. Active ocular disease in the operative eye other than cataract. 9. Vulnerable subjects as defined in section 12.3.9. 10. Corneal Astigmatism \> 4.5 D

Primary outcome measure(s)

Binocular distance corrected intermediate visual acuity (BCIDVA) — 6 months
The primary effectiveness endpoint is binocular distance corrected intermediate visual acuity (BCIDVA) at 70 cms at 6 months postoperative, with a target of equivalency between the two IOLs.

Trial sites (6)

Facility	City	Region	Status
Internationale Innovative Ophthalmochirurgie GbR	Düsseldorf	North Rhine-Westphalia	Recruiting
Augentagesklinik	Greven	North Rhine-Westphalia	Recruiting
Augentagesklinik	Rheine	North Rhine-Westphalia	Recruiting
Netradhama Superspeciality Eye Hospital	Bangalore	Karnatak	Not Yet Recruiting
Dr. Agarwal Eye Hospital	Chennai	Tamil Nadu	Recruiting
Hospital Arruzafa	Córdoba	Córdoba	Recruiting

Other trials for the same condition

Evaluation of Safety and Effectiveness of an IOL With a Virtual Aperture Optic Recruiting

MINIject Implantation Combined With Cataract Surgery in Patients With POAG and Cataract Enrolling by invitation

Evaluation of Orthokeratology Lenses With a 5MM Optic Zone Diameter Starting soon

Toric Performance And Constant Evaluation Recruiting

Safety and Efficacy of the Hydrophobic Intraocular Lens Asqelio Monofocal With Biaspheric Design Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07232615 on ClinicalTrials.gov ↗ ← All trials in Spain