Status:

RECRUITING

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

Lead Sponsor:

Biotech Healthcare Holding Gmbh

Conditions:

Presbyopia Correction

Astigmatism

Eligibility:

All Genders

21+ years

Phase:

NA

Brief 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 acui...

Detailed 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 int...

Eligibility Criteria

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

Key Trial Info

Start Date :

November 22 2021

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 1 2027

Estimated Enrollment :

138 Patients enrolled

Trial Details

Trial ID

NCT07232615

Start Date

November 22 2021

End Date

February 1 2027

Last Update

November 18 2025

Active Locations (6)

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Page 1 of 2 (6 locations)

1

Internationale Innovative Ophthalmochirurgie GbR

Düsseldorf, North Rhine-Westphalia, Germany, 40212

2

Augentagesklinik

Greven, North Rhine-Westphalia, Germany, 48268

3

Augentagesklinik

Rheine, North Rhine-Westphalia, Germany, 48429

4

Netradhama Superspeciality Eye Hospital

Bangalore, Karnatak, India, 560082