Actively 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
Led by Biotech Healthcare Holding Gmbh · Updated on 2025-11-18
138
Participants Needed
6
Research Sites
271 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official 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
Eligibility Criteria
You may qualify if you...
- 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 informed 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.
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
B
BHARGAV D JOSHI, M.Sc.
CONTACT
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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