Status:
ACTIVE_NOT_RECRUITING
Clinical Study to Investigate Outcomes of Trifocal Toric IOL POD FT in Asian Eyes
Lead Sponsor:
Beaver-Visitec International, Inc.
Conditions:
Cataract
Lens Opacities
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
Prospective, controlled, single-surgeon, single-center clinical study to compare visual acuity outcomes to data obtained in a similar study by the same principal investigator on the trifocal IOL POD F...
Detailed Description
This is a prospective, controlled, single-surgeon, single-center clinical study, whereby patients undergoing routine cataract surgery will have mono- or bilateral implantation of trifocal toric intrao...
Eligibility Criteria
Inclusion
- Male or female adults ages 45 years or older on the day of screening who have cataract(s) in one or both eyes or suffer from presbyopia;
- Regular corneal astigmatism ≥0.75 dioptres (measured by an automatic keratometer or biometer) in one or both eyes;
- Capability to understand and sign an IRB approved informed consent form and privacy authorization;
- Clear intraocular media other than cataract;
- Calculated IOL power is within the range of the study IOLs;
- Dilated pupil size large enough to visualize IOL axis markings postoperatively;
- Willing and able to conform to the study requirements.
Exclusion
- Regular corneal astigmatism \<0.75 dioptres (measured by an automatic keratometer or biometer) in both eyes
- Irregular astigmatism;
- Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse;
- Subjects with AMD suspicious eyes as determined by OCT examination;
- Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema;
- Previous intraocular or corneal surgery;
- Traumatic cataract;
- History or presence of macular edema;
- Pregnant, lactating or, if able to bear children, unwilling to use medically acceptable birth control over the course of the study;
- Concurrent or previous (within 30 days) participation in another drug or device investigation;
- Instability of keratometry or biometry measurements;
- Ocular hypertension or glaucoma;
- Significant dry eye;
- Unsuitable for study participation for any other reason, as determined by Investigator's clinical judgment (reason to be documented on eCRF).
Key Trial Info
Start Date :
March 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03844828
Start Date
March 25 2019
End Date
December 1 2025
Last Update
November 25 2025
Active Locations (1)
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1
Asian Eye Institute
Makati City, Philippines, 1200