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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

RecruitingNAAges 21 Years - anyAllBiotech Healthcare Holding Gmbh
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Optiflex TRIO Intraocular Lens
  • AcrySof® IQ PanOptix®
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Where

6 sites
Internationale Innovative Ophthalmochirurgie GbR
Düsseldorf, Germany
Augentagesklinik
Greven, Germany
Augentagesklinik
Rheine, Germany
Netradhama Superspeciality Eye Hospital
Bangalore, India
Dr. Agarwal Eye Hospital
Chennai, India
Hospital Arruzafa
Córdoba, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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