Clinical Study to Compare Visual Performance of Two Trifocal IOLs With Different Material (Hydrophobic and Hydrophilic)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions.
Study Overview
Brief Summary
Prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up study to compare the clinical outcomes of two trifocal IOLs with different material
Detailed Description
This is a prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up study whereby patients undergoing routine cataract surgery will have bilateral implantation of trifocal intraocular lenses. The patients will either be implanted with the hydrophobic IOL FineVision POD F GF or the hydrophilic IOL FineVision Pod F.
The primary and secondary effectiveness data for visual acuity, contrast sensitivity, halometry, aberrometry, questionnaire outcomes and any adverse events will be collected.
Subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 3 months. Subjects would have the option for unscheduled visits if required medically.
Primary endpoint data will be collected at the 3 months follow up visit. Data analyses will be done after the last patient finished the final examination to support the study publication plan.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- 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
- •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
- •Irregular astigmatism
- •Age of patient < 50 years
- •Regular corneal astigmatism >1.00 dioptres by an automatic keratometer or biometer or >1.25 dioptres if the steep axis of cylinder is between 90° and 120° in one or both eyes
- •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)
- •AMD suspicious eyes (determined by OCT)
- •Complicated surgery
Arms & Interventions
IOL implantation active comparator
hydrophilic, trifocal intraocular lens POD F
Intervention: IOL implantation active comparator (Device)
IOL implantation experimental
hydrophobic, trifocal intraocular lens POD F GF
Intervention: IOL implantation experimental (Device)
Outcomes
Primary Outcomes
monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions.
Time Frame: 3 months postoperative
The primary study end point is to show statistically equal visual acuity outcomes between both study groups. The primary study endpoint parameter is monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions. UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014
Secondary Outcomes
- Manifested refraction - Sphere(3 months postoperative)
- Manifested refraction - Cylinder(3 months postoperative)
- Uncorrected Distance Visual Acuity (UDVA)(3 months postoperative)
- Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA)(3 months postoperative)
- Distance Corrected Near Visual Acuity at 40cm (DCNVA)(3 months postoperative)
- Aberrometry - Tilt(3 months postoperative)
- OQAS II - OSI(3 months postoperative)
- Corrected Distance Visual Acuity (CDVA)(3 months postoperative)
- Distance Corrected Intermediate Visual Acuity at 63cm (DCIVA)(3 months postoperative)
- Distance Corrected Near Visual Acuity at 25cm (DCNVA)(3 months postoperative)
- Halometry(3 months postoperative)
- Contrast Sensitivity(3 months postoperative)
- Aberrometry - SA(3 months postoperative)
- Aberrometry - HOA(3 months postoperative)
- OQAS II - MTF(3 months postoperative)
- OQAS II - Strehl Ratio(3 months postoperative)
- questionnaire(3 months postoperative)