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

Biotech Healthcare Holding Gmbh138 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

138

Conditions

Presbyopia Correction Astigmatism Cataract

Interventions

Optiflex TRIO Intraocular LensDEVICE

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.

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (6)

Internationale Innovative Ophthalmochirurgie GbR

Düsseldorf, North Rhine-Westphalia, Germany

RECRUITING

Augentagesklinik

Greven, North Rhine-Westphalia, Germany

RECRUITING

Augentagesklinik

Rheine, North Rhine-Westphalia, Germany

RECRUITING

Netradhama Superspeciality Eye Hospital

Bangalore, Karnatak, India

NOT_YET_RECRUITING

Dr. Agarwal Eye Hospital

Chennai, Tamil Nadu, India

RECRUITING

Hospital Arruzafa

Córdoba, Córdoba, Spain

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 6 months

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

Overview

Conditions

Interventions

Eligibility

Locations (6)

Outcomes

Primary Outcomes

Central Contacts