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Recruiting 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

No phase Interventional Presbyopia Correction Astigmatism Cataract

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Optiflex TRIO Intraocular Lens, AcrySof® IQ PanOptix®.
Who it may be relevant to
Registry conditions: Presbyopia Correction, Astigmatism, Cataract. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany, India, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

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, distan
  • 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 intermedi

Primary outcome measures

  • Binocular distance corrected intermediate visual acuity (BCIDVA) [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 3 centers
  • Internationale Innovative Ophthalmochirurgie GbR — Düsseldorf
  • Augentagesklinik — Greven
  • Augentagesklinik — Rheine
India · 2 centers
  • Netradhama Superspeciality Eye Hospital — Bangalore
  • Dr. Agarwal Eye Hospital — Chennai
Spain · 1 center
  • Hospital Arruzafa — Córdoba

Identifiers

NCT: NCT07232615 · BTVCPL-TRITORIC-2019-18

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗