CataractNCT03027024
Clinical Study to Investigate Visual Performance of IOL: FineVision HP
A study testing Implantation of IOL: PhysIOL POD F GF in people with Cataract and Lens Opacity, run by Beaver-Visitec International, Inc. at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Lens Opacity
- What is being tested?
- Implantation of IOL: PhysIOL POD F GF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteAustralia
- Study dates
- 27 Feb 2017to 22 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Investigate Visual Performance of Hydrophobic Trifocal IOL: FineVision HP
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.
Read the 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.
- Conditions
- Cataract, Lens Opacity
- Being tested
- Implantation of IOL: PhysIOL POD F GF
- Keywords
- Intraocular Lens, trifocal, cataract, PhysIOL
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of IOL: PhysIOL POD F GFDevice
Also called PhysIOL HP
Implantation of trifocal IOL POD F GF consisting of hydrophobic material
| Study group | Role | What they receive |
|---|---|---|
| IOL Implantation | Experimental | Implantation of IOL: PhysIOL POD F GF Receives: Device: Implantation of IOL: PhysIOL POD F GF |
What is being measured
The primary outcome is the main question the study is designed to answer.
binocular Distance Corrected Near Visual Acuity (DCNVA)
measured in logMAR
Measured: 3 months postoperative
Secondary outcomes (7)
monocular and binocular Uncorrected Distance Visual Acuity (UDVA)
measured in logMAR
Measured: 3 months postoperative
monocular and binocular Corrected Distance Visual Acuity (CDVA)
measured in logMAR
Measured: 3 months postoperative
monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA)
measured in logMAR
Measured: 3 months postoperative
monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA)
measured in logMAR
Measured: 3 months postoperative
monocular and binocular Uncorrected Near Visual Acuity (UNVA)
measured in logMAR
Measured: 3 months postoperative
monocular and binocular Distance Corrected Near Visual Acuity (DCNVA)
measured in logMAR
Measured: 3 months postoperative
Contrast Sensitivity (mesopic and photopic)
measured in logCS
Measured: 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study start27 Feb 2017
- Primary completion22 Oct 2018
- Study completion22 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaver-Visitec International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Uday Bhatt, MD, Principal investigator, Vision Eye Institute - Footscray
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03027024
- Sponsor's protocol ID
- PHY 1602
- Status last verified
- May 2021
- First submitted
- 16 Jan 2017
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Investigate Visual Performance of Hydrophobic Trifocal IOL: FineVision HP
- ClinicalTrials.gov ID
- NCT03027024
- Acronym / sponsor ID
- PHY 1602
- Conditions
- Cataract, Lens Opacity
- Keywords
- Intraocular Lens, trifocal, cataract, PhysIOL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Beaver-Visitec International, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 22 Oct 2018 (actual)
- Study completion
- 22 Oct 2018 (actual)
- First posted
- 20 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IOL Implantation | Experimental | Device: Implantation of IOL: PhysIOL POD F GFImplantation of IOL: PhysIOL POD F GF |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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…)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of IOL: PhysIOL POD F GFAlso: PhysIOL HPImplantation of trifocal IOL POD F GF consisting of hydrophobic material | Device | IOL Implantation |
Primary outcome
binocular Distance Corrected Near Visual Acuity (DCNVA)
Time frame: 3 months postoperative
measured in logMAR
7 secondary outcomes
monocular and binocular Uncorrected Distance Visual Acuity (UDVA)
Time frame: 3 months postoperative
monocular and binocular Corrected Distance Visual Acuity (CDVA)
Time frame: 3 months postoperative
monocular and binocular Uncorrected Intermediate Visual Acuity (UIVA)
Time frame: 3 months postoperative
monocular and binocular Distance Corrected Intermediate Visual Acuity (DCIVA)
Time frame: 3 months postoperative
monocular and binocular Uncorrected Near Visual Acuity (UNVA)
Time frame: 3 months postoperative
monocular and binocular Distance Corrected Near Visual Acuity (DCNVA)
Time frame: 3 months postoperative
Contrast Sensitivity (mesopic and photopic)
Time frame: 3 months postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uday Bhatt, MD principal investigator
Vision Eye Institute - Footscray
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of IOL: PhysIOL POD F GF in people with Cataract and Lens Opacity, run by Beaver-Visitec International, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
binocular Distance Corrected Near Visual Acuity (DCNVA) (time frame: 3 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.