Cataract, Lens Opacity
Conditions
Keywords
Intraocular Lens, trifocal, cataract, PhysIOL
Brief summary
This is a prospective, non-randomised, controlled, single-surgeon, single-center post-market clinical follow up study whereby patient undergoing routine cataract surgery will have bilateral implantation of a recently introduced TGA (Therapeutics Goods Authority, Australia) approved trifocal intraocular lens FineVision Evo (PhysIOL, Liège, Belgium). The primary and secondary effectiveness data for visual acuity, defocus curves, contrast sensitivity and any adverse events will be collected.
Detailed description
Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 3 months, same as the surgeon's standard follow up protocol for bilateral cataract surgery with IOL implantation. Subjects would have the option for unscheduled visits if required medically. Primary endpoint data will be collected at the final visit. Data analyses will be done in the end to support the study publication plan.
Interventions
DEVICEImplantation of IOL: PhysIOL POD F GF
Implantation of trifocal IOL POD F GF consisting of hydrophobic material
Sponsors
Beaver-Visitec International, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Cataracteous 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 criteria
* Unrealistic expectation * Irregular astigmatism * Regular corneal astigmatism \>0.75 D on one or both eyes as measured by an automatic keratometer (regularity determined by the topography of the keratometry) * 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) * Complicated surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| binocular Distance Corrected Near Visual Acuity (DCNVA) | 3 months postoperative | measured in logMAR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| monocular and binocular Uncorrected Distance Visual Acuity (UDVA) | 3 months postoperative | measured in logMAR |
| monocular and binocular Corrected Distance Visual Acuity (CDVA) | 3 months postoperative | measured in logMAR |
| monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA) | 3 months postoperative | measured in logMAR |
| monocular and binocular Uncorrected Near Visual Acuity (UNVA) | 3 months postoperative | measured in logMAR |
| monocular and binocular Distance Corrected Near Visual Acuity (DCNVA) | 3 months postoperative | measured in logMAR |
| Contrast Sensitivity (mesopic and photopic) | 3 months postoperative | measured in logCS |
| monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA) | 3 months postoperative | measured in logMAR |
Countries
Australia
Outcome results
None listed