Clinical trial NCT03027024: Clinical Study to Investigate Visual Performance of IOL: FineVision HP
Official title: Clinical Study to Investigate Visual Performance of Hydrophobic Trifocal IOL: FineVision HP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lens Opacity
Keywords: Intraocular Lens
trifocal
cataract
PhysIOL
Lead sponsor: Beaver-Visitec International, Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-20
Enrollment: 22
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: binocular Distance Corrected Near Visual Acuity (DCNVA)
timeFrame: 3 months postoperative
Secondary outcomes:
measure: monocular and binocular Uncorrected Distance Visual Acuity (UDVA)
timeFrame: 3 months postoperative
measure: monocular and binocular Corrected Distance Visual Acuity (CDVA)
timeFrame: 3 months postoperative
measure: monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA)
timeFrame: 3 months postoperative
measure: monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA)
timeFrame: 3 months postoperative
measure: monocular and binocular Uncorrected Near Visual Acuity (UNVA)
timeFrame: 3 months postoperative
measure: monocular and binocular Distance Corrected Near Visual Acuity (DCNVA)
timeFrame: 3 months postoperative
measure: Contrast Sensitivity (mesopic and photopic)
timeFrame: 3 months postoperative
Other outcomes:
Locations:
city: Footscray
country: Australia
facility: Vision Eye Institute
state: Victoria
Study officials:
affiliation: Vision Eye Institute - Footscray
name: Uday Bhatt, MD
role: PRINCIPAL_INVESTIGATOR
References: