Clinical trial NCT03688399: Comparison of Clinical Outcomes POD L GF vs POD F GF (PHY1707)
Official title: Clinical Study to Compare Clinical Outcomes of Hydrophobic Trifocal IOLs FineVision POD F GF and FineVision POD L GF After Bilateral Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lens Opacity
Presbyopia
Keywords: Intraocular Lens
trifocal
cataract
PhysIOL
Lead sponsor: Beaver-Visitec International, Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-28
Enrollment: 53
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, randomised, controlled, single-surgeon, single-center clinical study to compare the clinical outcomes of two trifocal IOLs differing in the dominance of additional power. The investigational device POD L GF shows dominance for the intermediate addition (+1.75 D), whereas the control device POD F GF shows dominance for the near addition (+3.5 D). Implantation of the IOLs is bilaterally.

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 intraocular lenses. The patients will either be implanted with the hydrophobic IOL FineVision POD L GF or the hydrophobic IOL FineVision POD F GF (both lenses: (PhysIOL, Liège, Belgium).

The devices under investigation (FineVision POD L GF and POD F GF) are trifocal glistening-free acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. Both consist of the same hydrophobic material. The main difference between the lenses is the dominance of additional power. The investigational device POD L GF shows dominance for the intermediate addition (+1.75 D), whereas the control device POD F GF shows dominance for the near addition (+3.5 D). The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

Subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 6 months. Subjects would have the option for unscheduled visits if required medically.

Primary and secondary endpoint data will be collected at the 6 months follow up visit. Data analyses will be done after the last patient finished the final examination to support the study publication plan.

Eligibility criteria: Inclusion Criteria:

* Cataractous eyes and/or patients suffering from presbyopia with no ocular comorbidity
* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Signed informed consent

Exclusion Criteria:

* Age of patient \<40 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)
* AMD suspicious eyes
* Complicated surgery

Primary outcomes:
measure: Monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions.
timeFrame: 3 months postoperative
Secondary outcomes:
measure: Manifested refraction
timeFrame: 3 months postoperative
measure: Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
timeFrame: 3 months postoperative
measure: Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions
timeFrame: 6 months postoperative
measure: Corrected Distance Visual Acuity (CDVA) under photopic light conditions
timeFrame: 3 months postoperative
measure: Corrected Distance Visual Acuity (CDVA) under mesopic light conditions
timeFrame: 6 months postoperative
measure: Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) under photopic light conditions
timeFrame: 3 months postoperative
measure: Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) under mesopic light conditions
timeFrame: 6 months postoperative
measure: Uncorrected Intermediate Visual Acuity at 70cm (UIVA) under photopic light conditions
timeFrame: 3 months postoperative
measure: Uncorrected Intermediate Visual Acuity at 70cm (UIVA) under mesopic light conditions
timeFrame: 6 months postoperative
measure: Distance Corrected Near Visual Acuity at 35cm (DCNVA) under photopic light conditions
timeFrame: 3 months postoperative
measure: Distance Corrected Near Visual Acuity at 35cm (DCNVA) under mesopic light conditions
timeFrame: 6 months postoperative
measure: Uncorrected Near Visual Acuity at 35cm (UNVA) under photopic light conditions
timeFrame: 3 months postoperative
measure: Uncorrected Near Visual Acuity at 35cm (UNVA) under mesopic light conditions
timeFrame: 6 months postoperative
measure: Contrast Sensitivity (monocular)
timeFrame: 6 months postoperative
measure: Contrast Sensitivity (binocular)
timeFrame: 3 months postoperative
measure: Questionnaire: Visual Functioning Questionnaire - 25 (VFQ-25, National Eye Institute)
timeFrame: 3 months postoperative
measure: Defocus Curve monocular
timeFrame: 1 month postoperative
measure: Defocus Curve binocular
timeFrame: 3 months postoperative
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Semmelweis University - Department of Ophthalmology
Study officials:
affiliation: Semmelweis University - Department of Ophthalmology
name: Zoltan Nagy, MD
role: PRINCIPAL_INVESTIGATOR
References: