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NCT Number: NCT07232615

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

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.

Recruiting

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Internationale Innovative Ophthalmochirurgie GbR, Düsseldorf, North Rhine-Westphalia, Germany

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About this study

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 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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

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.

Primary outcomes

  1. Binocular distance corrected intermediate visual acuity (BCIDVA)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

BHARGAV D JOSHI, M.Sc.

CONTACT

[email protected]

+917966823000 ext. 203

Sponsors and collaborators

Lead sponsor

Biotech Healthcare Holding Gmbh

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Nov 18, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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