NCT02981186CompletedNot Applicable
Comparison of Visual Outcomes After Implantation of the POD AY GF F (PhysIOL) and the POD AY 26P F (PhysIOL)
Beaver-Visitec International, Inc.2 sites in 1 country25 target enrollmentStarted: November 2, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Visual Acuity at far, near and intermediate distance
Study Overview
Brief Summary
The study is a prospective randomised controlled study. The patients get monolateral IOL implantation of POD F GF and POD F in the contralateral eye. Both IOLs are trifocal IOLs consisting of the same optical design. The difference between the IOLs is the material (hydrophilic and hydrophobic).
To decide which eye receives POD F and which eye receives POD F GF, a randomization table will be provided to the principle investigator.
Detailed Description
The examinations consist of visual acuity data, contrast sensitivity exams and slitlamp examinations.
Follow up will be up to 6 months postoperative.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Cataractous Eyes with no comorbidity
- •Patient older than 50 years old
- •Regular corneal astigmatism <0.75 dioptres by an automatic keratometer (regularity determined by the topography of the keratometry) or <1.0 dioptres if the steep axis of cylinder is between 90° and 120°
- •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 Criteria
- •Unrealistic expectation
- •Irregular astigmatism
- •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)
Outcomes
Primary Outcomes
Visual Acuity at far, near and intermediate distance
Time Frame: 6 months postoperative
ability to read letters at different distances
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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