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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

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03027024