A Prospective, Multicenter Clinical Study Comparing Outcomes of Two Trifocal Toric Intraocular Lens
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Germany
Internationale Innovative Ophthalmochirurgie GbR
RECRUITING
Düsseldorf
Augentagesklinik
RECRUITING
Greven
Augentagesklinik
RECRUITING
Rheine
India
Netradhama Superspeciality Eye Hospital
NOT_YET_RECRUITING
Bangalore
Dr. Agarwal Eye Hospital
RECRUITING
Chennai
Spain
Hospital Arruzafa
RECRUITING
Córdoba
Contact Information
Primary
BHARGAV D JOSHI, M.Sc.
bhargav.joshi@biotechhealthcare.com
+917966823000
Time Frame
Start Date: 2021-11-22
Estimated Completion Date: 2027-02
Participants
Target number of participants: 138
Treatments
Experimental: Optiflex TRIO (Biotech Europe Meditech Inc. Ltd.)
Patients will be implanted with Optiflex TRIO (Biotech Europe Meditech Inc. Ltd.) IOL based on randomization
Active_comparator: AcrySof® IQ PanOptix® (Alcon Laboratories, Inc.)
Patients will be implanted with AcrySof® IQ PanOptix® (Alcon Laboratories, Inc.) based on randomization
Related Therapeutic Areas
Sponsors
Leads: Biotech Healthcare Holding Gmbh