A Planned Study at Multiple Sites is Being Done to Compare the Results of Two Types of Trifocal T… (NCT07232615) | Clinical Trial Compass
RecruitingNot Applicable
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
Germany, India138 participantsStarted 2021-11-22
Plain-language 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.
Who can participate
Age range21 Years
SexALL
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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.