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:
- 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.
- Patient willing to sign inform consent form.
- Clear intraocular media other than cataract.
- Female participants of childbearing potential must be willing to ensure that they use effective contraception during the study.
Exclusion Criteria:
- Previous intraocular or corneal surgery.
- Traumatic cataract
- Pregnancy (as stated by patient) or lactation.
- Concurrent participation in another drug or device investigation.
- Irregular astigmatism.
- Patient receiving chlorquine treatment.
- Subjects with any systemic disease that could increase operative risk or confound the outcome.
- Active ocular disease in the operative eye other than cataract.
- Vulnerable subjects as defined in section 12.3.9.
- 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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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