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 | Recruiting DMC

• 1 other identifier: BTVCPL-TRITORIC-2019-18
• Study Type: interventional
• Target: 138
• Locations: 3 countries
• Sites: 6

Brief 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.

Conditions

Presbyopia Correction; Astigmatism; Cataract

Outcome Measures

Primary Outcomes (1)

• Binocular distance corrected intermediate visual acuity (BCIDVA)

  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.

  6 months

Study Arms (2)

Optiflex TRIO (Biotech Europe Meditech Inc. Ltd.)

EXPERIMENTAL

Patients will be implanted with Optiflex TRIO (Biotech Europe Meditech Inc. Ltd.) IOL based on randomization

Device: Optiflex TRIO Intraocular Lens

AcrySof® IQ PanOptix® (Alcon Laboratories, Inc.)

ACTIVE COMPARATOR

Patients will be implanted with AcrySof® IQ PanOptix® (Alcon Laboratories, Inc.) based on randomization

Device: AcrySof® IQ PanOptix®

Interventions

Optiflex TRIO Intraocular Lens DEVICE

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

Optiflex TRIO (Biotech Europe Meditech Inc. Ltd.)

AcrySof® IQ PanOptix® DEVICE

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.

AcrySof® IQ PanOptix® (Alcon Laboratories, Inc.)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of patient \>21 Years
• Patient diagnosed with cataract.
• Patient must have preoperative regular corneal astigmatism between 0.75 to 4.5 D as per corneal topography or keratometry
• Calculated IOL power is within the range of investigational IOLs.
• Patient willing to sign inform consent form.
• Clear intraocular media other than cataract.
• Female participants of childbearing potential must be willing to ensure that they use effective contraception during the study.

You may not qualify if:

• Previous intraocular or corneal surgery.
• Traumatic cataract
• Pregnancy (as stated by patient) or lactation.
• Concurrent participation in another drug or device investigation.
• Irregular astigmatism.
• Patient receiving chlorquine treatment.
• Subjects with any systemic disease that could increase operative risk or confound the outcome.
• Active ocular disease in the operative eye other than cataract.
• Vulnerable subjects as defined in section 12.3.9.
• Corneal Astigmatism \> 4.5 D

Sponsors & Collaborators

• Biotech Healthcare Holding Gmbh: lead

Study Sites (6)

Internationale Innovative Ophthalmochirurgie GbR

Düsseldorf, North Rhine-Westphalia, 40212, Germany

RECRUITING

Augentagesklinik

Greven, North Rhine-Westphalia, 48268, Germany

RECRUITING

Augentagesklinik

Rheine, North Rhine-Westphalia, 48429, Germany

RECRUITING

Netradhama Superspeciality Eye Hospital

Bangalore, Karnatak, 560082, India

NOT YET RECRUITING

Dr. Agarwal Eye Hospital

Chennai, Tamil Nadu, 600018, India

RECRUITING

Hospital Arruzafa

Córdoba, Córdoba, 14012, Spain

RECRUITING

MeSH Terms

Conditions

Astigmatism; Cataract

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Lens Diseases

Central Study Contacts

BHARGAV D JOSHI, M.Sc.

CONTACT

+917966823000; bhargav.joshi@biotechhealthcare.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Trifocal Toric Intraocular lens are indicated for primary implantation for visual aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia who wish to gain near, intermediate and distance vision with decreased dependency on spectacles

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: November 22, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

IN (2); DE (3); ES (1)