Clinical trial NCT03306342: Visual Performance, Patient Satisfaction and PCO Rate After Implantation of a Trifocal Hydrophobic IOL
Official title: Clinical Study to Investigate Visual Performance, Patient Satisfaction and PCO Rate After Implantation of a Trifocal Hydrophobic IOL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lens Opacities
Presbyopia
Keywords: Intraocular Lens
trifocal
hydrophobic
hydrophilic
Lead sponsor: Beaver-Visitec International, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-11
Enrollment: 25
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prospective, controlled, single-surgeon, single-center post-market clinical follow up study to investigate the clinical outcomes of a hydrophobic trifocal IOL (PhysIOL POD F GF)

Detailed description: This clinical investigation is a prospective, 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 FineVision POD F GF (PhysIOL, Liège, Belgium).

The study purpose is to obtain clinical data on visual acuity, contrast sensitivity, questionnaire outcomes and PCO rate on patients implanted with FineVision POD F GF.

The device under investigation (FineVision POD F GF) is a trifocal glistening-free hydrophobic acrylic intraocular lens (IOL) manufactured by the sponsor of this study PhysIOL sa/nv. The IOL will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

In total 25 patients will be recruited for this clinical study and receive a bilateral implantation of FineVision POD F GF intraocular lens.

Subjects participating in the trial will attend a total of 8 study visits (1 preoperative, 2 operative and 5 postoperative) over a period of 24 months.

Eligibility criteria: 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 \< 45 years
* 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° 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

Primary outcomes:
measure: binocular Uncorrected Distance Visual Acuity (UDVA)
timeFrame: 3 months postoperative
Secondary outcomes:
measure: Manifested refraction
timeFrame: 3 months postoperative
measure: Uncorrected Distance Visual Acuity (UDVA)
timeFrame: 3 months postoperative
measure: Corrected Distance Visual Acuity (CDVA)
timeFrame: 3 months postoperative
measure: Distance Corrected Intermediate Visual Acuity (DCIVA)
timeFrame: 3 months postoperative
measure: Uncorrected Intermediate Visual Acuity (UIVA)
timeFrame: 3 months postoperative
measure: Distance Corrected Near Visual Acuity (DCNVA)
timeFrame: 3 months postoperative
measure: Uncorrected Near Visual Acuity (UNVA)
timeFrame: 3 months postoperative
measure: Contrast Sensitivity
timeFrame: 3 months postoperative
measure: Aberrometry
timeFrame: 3 months postoperative
measure: PCO rate
timeFrame: 2 years postoperative
measure: questionnaire
timeFrame: 3 months postoperative
Other outcomes:
Locations:
city: Brest
country: France
facility: Département d'ophtalmologie - CHU Morvan Bâtiment 4 bis
Study officials:
affiliation: Département d'ophtalmologie - CHU Morvan Bâtiment 4 bis
name: Béatrice Cochener, Prof.
role: PRINCIPAL_INVESTIGATOR
References: