RecruitingNot ApplicableNCT07232615

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

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

Sponsor

Biotech Healthcare Holding Gmbh

Enrollment

138 participants

Start Date

Nov 22, 2021

Study Type

INTERVENTIONAL

Conditions

Astigmatism Cataract Presbyopia Correction

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

Min Age: 21 Years

Inclusion Criteria7

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 Criteria10

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

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Interventions

DEVICEOptiflex 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

DEVICEAcrySof® 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.