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Recruiting NCT07232615

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

Trial Parameters

Condition Presbyopia Correction
Sponsor Biotech Healthcare Holding Gmbh
Study Type INTERVENTIONAL
Phase N/A
Enrollment 138
Sex ALL
Min Age 21 Years
Max Age N/A
Start Date 2021-11-22
Completion 2026-12
Interventions
Optiflex TRIO Intraocular LensAcrySof® IQ PanOptix®

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 acuity between the two trifocal toric intraocular lenses. Secondary Objectives: To assess and compare the safety of two trifocal toric intraocular lenses.

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

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