Status:
COMPLETED
Comparison of Clinical Outcomes on Trifocal IOLs FineVision POD F GF and FineVision POD F in Asian Eyes
Lead Sponsor:
Beaver-Visitec International, Inc.
Conditions:
Cataract
Lens Opacities
Eligibility:
All Genders
45+ years
Phase:
NA
Brief Summary
Prospective, randomised, controlled, single-surgeon, single-center clinical study to compare the clinical outcomes of two trifocal IOLs with different material (hydrophobic and hydrophilic) from the s...
Detailed Description
This is a prospective, randomised, controlled, single-surgeon, single-center clinical study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocula...
Eligibility Criteria
Inclusion
- Cataractous eyes with no comorbidity
- Spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation.
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- Signed informed consent
Exclusion
- Unrealistic expectation
- 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)
- Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)
- Any ocular comorbidity
- History of ocular trauma or prior ocular surgery including refractive procedures
- Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
- Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
- Age-related Macular Degeneration (AMD) suspicious eyes (determined by OCT)
- Complicated surgery
Key Trial Info
Start Date :
December 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 10 2022
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT03306355
Start Date
December 4 2017
End Date
February 10 2022
Last Update
July 27 2023
Active Locations (1)
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1
Asian Eye Institute
Makati City, Philippines, 1200