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

ConditionsPresbyopia Correction Astigmatism Cataract

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21+

SponsorBiotech Healthcare Holding Gmbh

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Previous intraocular or corneal surgery.

Traumatic cataract

Pregnancy (as stated by patient) or lactation.

Concurrent participation in another drug or device investigation.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

138 Participants

are divided into 2 treatment groups

Group A: Optiflex TRIO (Biotech Europe Meditech Inc. Ltd.)Experimental treatment 1 intervention

Group B: AcrySof® IQ PanOptix® (Alcon Laboratories, Inc.)Active comparator 1 intervention

Trial 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