Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
ID07232615

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

Led by Biotech Healthcare Holding Gmbh · Updated on 2025-11-18

138

Participants Needed

6

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two commercially available trifocal toric intraocular lenses to compare their clinical outcomes and patient satisfaction in people undergoing cataract surgery. The main goal is to compare the distance-corrected intermediate visual acuity provided by these lenses. Additionally, the study aims to assess and compare the safety of the two trifocal toric intraocular lenses designed to correct astigmatism and improve vision at near, intermediate, and distance ranges. Participants will be randomly assigned to receive one of two types of trifocal toric intraocular lenses: Optiflex TRIO or AcrySof IQ PanOptix. Both lenses are single-piece, posterior chamber foldable intraocular lenses with advanced aspheric optics and a trifocal design intended to reduce dependence on glasses. The Optiflex TRIO features a refractive-diffractive trifocal toric optic with a square edge design, while the AcrySof IQ PanOptix has a diffractive trifocal optic with a toric component. Each participant will receive one of these lenses based on randomization during cataract surgery. During the study, participants will be monitored for visual acuity outcomes, focusing on binocular distance-corrected intermediate vision at six months after lens implantation. Researchers will also track patient satisfaction and safety throughout the study period. The study includes preoperative assessments such as corneal topography or keratometry to measure astigmatism and will involve follow-ups to evaluate visual performance and any adverse effects. The total duration of participation varies but includes at least a six-month follow-up for outcome measurement.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age of patient >21 Years
  • Patient diagnosed with cataract
  • 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 informed consent form
  • Clear intraocular media other than cataract
  • Female participants of childbearing potential must use effective contraception during the study
Not Eligible

You will not qualify if you...

  • Previous intraocular or corneal surgery
  • Traumatic cataract
  • Pregnancy or lactation
  • Concurrent participation in another drug or device investigation
  • Irregular astigmatism
  • Patient receiving chlorquine treatment
  • Systemic disease increasing operative risk or confounding outcome
  • Active ocular disease in operative eye other than cataract
  • Vulnerable subjects as defined in protocol
  • Corneal astigmatism > 4.5 D

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Day of surgery

Participants will undergo cataract surgery where one of two types of trifocal toric intraocular lenses will be implanted based on randomization.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - Up to 6 months

Participants will be monitored after surgery to assess visual outcomes and recovery.

Multiple follow-up visits over 6 months

Trial Site Locations

Total: 6 locations

1

Internationale Innovative Ophthalmochirurgie GbR

Düsseldorf, North Rhine-Westphalia, Germany, 40212

Actively Recruiting

2

Augentagesklinik

Greven, North Rhine-Westphalia, Germany, 48268

Actively Recruiting

3

Augentagesklinik

Rheine, North Rhine-Westphalia, Germany, 48429

Actively Recruiting

4

Netradhama Superspeciality Eye Hospital

Bangalore, Karnatak, India, 560082

Not Yet Recruiting

5

Dr. Agarwal Eye Hospital

Chennai, Tamil Nadu, India, 600018

Actively Recruiting

6

Hospital Arruzafa

Córdoba, Córdoba, Spain, 14012

Actively Recruiting

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Research Team

B

BHARGAV D JOSHI, M.Sc.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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