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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03027024




Registration number
NCT03027024
Ethics application status
Date submitted
16/01/2017
Date registered
20/01/2017
Date last updated
6/05/2021

Titles & IDs
Public title
Clinical Study to Investigate Visual Performance of IOL: FineVision HP
Scientific title
Clinical Study to Investigate Visual Performance of Hydrophobic Trifocal IOL: FineVision HP
Secondary ID [1] 0 0
PHY 1602
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataract 0 0
Lens Opacity 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Implantation of IOL: PhysIOL POD F GF

Experimental: IOL Implantation - Implantation of IOL: PhysIOL POD F GF


Treatment: Devices: Implantation of IOL: PhysIOL POD F GF
Implantation of trifocal IOL POD F GF consisting of hydrophobic material
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
binocular Distance Corrected Near Visual Acuity (DCNVA)
Timepoint [1] 0 0
3 months postoperative
Secondary outcome [1] 0 0
monocular and binocular Uncorrected Distance Visual Acuity (UDVA)
Timepoint [1] 0 0
3 months postoperative
Secondary outcome [2] 0 0
monocular and binocular Corrected Distance Visual Acuity (CDVA)
Timepoint [2] 0 0
3 months postoperative
Secondary outcome [3] 0 0
monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA)
Timepoint [3] 0 0
3 months postoperative
Secondary outcome [4] 0 0
monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA)
Timepoint [4] 0 0
3 months postoperative
Secondary outcome [5] 0 0
monocular and binocular Uncorrected Near Visual Acuity (UNVA)
Timepoint [5] 0 0
3 months postoperative
Secondary outcome [6] 0 0
monocular and binocular Distance Corrected Near Visual Acuity (DCNVA)
Timepoint [6] 0 0
3 months postoperative
Secondary outcome [7] 0 0
Contrast Sensitivity (mesopic and photopic)
Timepoint [7] 0 0
3 months postoperative

Eligibility
Key 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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/02/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/10/2018
Sample size
Target
Accrual to date
Final
22
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Vision Eye Institute - Footscray
Recruitment postcode(s) [1] 0 0
3011 - Footscray

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Beaver-Visitec International, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT03027024
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Uday Bhatt, MD
Address 0 0
Vision Eye Institute - Footscray
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03027024