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 Gmbh

Status: Enrolling

Conditions: Presbyopia Correction; Cataract; Astigmatism

Treatments: Device: Optiflex TRIO Intraocular Lens; Device: AcrySof® IQ PanOptix®

Study type: Interventional

Funder types: Industry

Identifiers

NCT07232615

BTVCPL-TRITORIC-2019-18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

Optiflex TRIO (Biotech Europe Meditech Inc. Ltd.)

Experimental group

Description:

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

Treatment:

Device: Optiflex TRIO Intraocular Lens

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

Active Comparator group

Description:

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

Treatment:

Device: AcrySof® IQ PanOptix®