Cataract, Lens Opacity
Conditions
Keywords
Intraocular Lens, trifocal, cataract, PhysIOL
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.
Interventions
Implantation of trifocal IOL POD F GF consisting of hydrophobic material
Implantation of trifocal IOL POD F consisting of hydrophilic material
Sponsors
Beaver-Visitec International, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity at far, near and intermediate distance | 6 months postoperative | ability to read letters at different distances |
Countries
Hungary
Outcome results
None listed