Status:
COMPLETED
Clinical Outcomes of MICROPURE and PodEye Monofocal Intraocular Lenses
Lead Sponsor:
Beaver-Visitec International, Inc.
Conditions:
Cataract
Lens Opacities
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
Prospective, non-randomised, open, controlled, single-center post-market clinical follow study about Micropure 1.2.3. and PODEYE intraocular lenses.
Detailed Description
This clinical investigation is a prospective, non-randomised, open, controlled, single-center post-market clinical follow whereby study patients undergoing routine cataract surgery will have implantat...
Eligibility Criteria
Inclusion
- Cataractous eyes with no comorbidity
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- Clear intraocular media other than cataract;
- Signed informed consent
Exclusion
- Age of patient \< 45 years;
- Irregular astigmatism;
- Regular corneal astigmatism \>0.75 dioptres by an automatic keratometer or biometer or \>1.0 dioptres if the steep axis of cylinder is between 90° and 120°;
- Difficulty for cooperation (distance from their home, general health condition);
- Previous intraocular or corneal surgery;
- Traumatic cataract;
- Any ocular comorbidity;
- Instability of keratometry or biometry measurements.
Key Trial Info
Start Date :
February 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2021
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT03796624
Start Date
February 12 2019
End Date
June 17 2021
Last Update
July 9 2021
Active Locations (1)
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1
GEMINI Eye Clinic
Zlín, Czechia, 76001