CataractPHY1702NCT03347981
Clinical Study to Compare Visual Performance of Two Trifocal IOLs
A study testing IOL implantation experimental and IOL implantation active comparator in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 1 site in Spain.
Trial summary
Prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up study to compare the clinical outcomes of two trifocal IOLs with different material 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 Opacities, Presbyopia
- What is being tested?
- IOL implantation experimental and IOL implantation active comparator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSpain
- Study dates
- 2 Oct 2017to 21 May 2019
- 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
- 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
Who cannot join
- Irregular astigmatism
- Age of patient < 50 years
- Regular corneal astigmatism >1.00 dioptres by an automatic keratometer or biometer or >1.25 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
Show all 11Show 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)
- AMD suspicious eyes (determined by OCT)
- Complicated surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Compare Visual Performance of Two Trifocal IOLs With Different Material (Hydrophobic and Hydrophilic)
Prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up study to compare the clinical outcomes of two trifocal IOLs with different material
Read the detailed description
This is a prospective, randomised, 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. The patients will either be implanted with the hydrophobic IOL FineVision POD F GF or the hydrophilic IOL FineVision Pod F.
The primary and secondary effectiveness data for visual acuity, contrast sensitivity, halometry, aberrometry, questionnaire outcomes and any adverse events will be collected.
Subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 3 months. Subjects would have the option for unscheduled visits if required medically.
Primary endpoint data will be collected at the 3 months follow up visit. Data analyses will be done after the last patient finished the final examination to support the study publication plan.
- Conditions
- Cataract, Lens Opacities, Presbyopia
- Being tested
- IOL implantation experimental, IOL implantation active comparator
- Keywords
- Intraocular Lens, trifocal, hydrophobic, hydrophilic
- Medical subject headings
- Cataract, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOL implantation experimentalDevice
Implantation of trifocal IOL POD F GF consisting of hydrophobic material
IOL implantation active comparatorDevice
Implantation of trifocal IOL POD F consisting of hydrophilic material
| Study group | Role | What they receive |
|---|---|---|
| IOL implantation experimental | Experimental | hydrophobic, trifocal intraocular lens POD F GF Receives: Device: IOL implantation experimental |
| IOL implantation active comparator | Active comparator | hydrophilic, trifocal intraocular lens POD F Receives: Device: IOL implantation active comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions.
The primary study end point is to show statistically equal visual acuity outcomes between both study groups. The primary study endpoint parameter is monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions. UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014
Measured: 3 months postoperative
Secondary outcomes (17)
Manifested refraction - Sphere
The spherical part of the manifested refraction is measured by means of a phoropter. The examination is done according to ISO 11979-7:2014.
Measured: 3 months postoperative
Manifested refraction - Cylinder
The cylindrical part of the manifested refraction is measured by means of a phoropter. Amount of cylinder and cylinder axis will be noted. The examination is done according to ISO 11979-7:2014. This data will also be used to calculate the manifested refractive spherical equivalent (MRSE)
Measured: 3 months postoperative
Uncorrected Distance Visual Acuity (UDVA)
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done binocularly.
Measured: 3 months postoperative
Corrected Distance Visual Acuity (CDVA)
CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Measured: 3 months postoperative
Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA)
DCIVA is measured with Radner reading charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Measured: 3 months postoperative
Distance Corrected Intermediate Visual Acuity at 63cm (DCIVA)
DCIVA is measured with ETDRS charts placed in 63cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Measured: 3 months postoperative
Distance Corrected Near Visual Acuity at 40cm (DCNVA)
DCNVA is measured with Radner reading charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Measured: 3 months postoperative
Distance Corrected Near Visual Acuity at 25cm (DCNVA)
DCNVA is measured with Radner reading charts placed in 25cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.
Measured: 3 months postoperative
Halometry
Halometry outcomes, measurement by halos software v1.0
Measured: 3 months postoperative
Contrast Sensitivity
Contrast Sensitivity under photopic and mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)
Measured: 3 months postoperative
Aberrometry - SA
Aberrometry outcomes are measured with a standard aberrometer. In this examination, the following values will be evaluated: Spherical aberration
Measured: 3 months postoperative
Aberrometry - HOA
Aberrometry outcomes are measured with a standard aberrometer. In this examination, the following values will be evaluated: High Order Aberrations
Measured: 3 months postoperative
Aberrometry - Tilt
Aberrometry outcomes are measured with a standard aberrometer. In this examination, the following values will be evaluated: lens tilt
Measured: 3 months postoperative
OQAS II - OSI
Outcomes of OQAS II diagnostic device (Ocular Scatter Index)
Measured: 3 months postoperative
OQAS II - MTF
Outcomes of OQAS II diagnostic device (Modular Transfer Function)
Measured: 3 months postoperative
OQAS II - Strehl Ratio
Outcomes of OQAS II diagnostic device (Strehl Ratio)
Measured: 3 months postoperative
questionnaire
Outcomes measures of a questionnaire to address the general patient satisfaction and possible side effects of the treatment. For this study, the validated and verified questionnaire VFQ-25 (National Eye Institute) will be used. The maximum score for each question is 100. The scoring and evaluation of the questionnaire will be done according to the official guidelines and manual provided by National Eye Institute
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 Nov 2017
- Study start2 Oct 2017
- Primary completion21 May 2019
- Study completion21 May 2019
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaver-Visitec International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francisco Poyales Galan, MD, Principal investigator, Innova Ocular IOA Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03347981
- Sponsor's protocol ID
- PHY1702
- Acronym
- PHY1702
- Status last verified
- May 2021
- First submitted
- 26 Sep 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 Compare Visual Performance of Two Trifocal IOLs With Different Material (Hydrophobic and Hydrophilic)
- ClinicalTrials.gov ID
- NCT03347981
- Acronym / sponsor ID
- PHY1702 / PHY1702
- Conditions
- Cataract, Lens Opacities, Presbyopia
- Keywords
- Intraocular Lens, trifocal, hydrophobic, hydrophilic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Beaver-Visitec International, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 21 May 2019 (actual)
- Study completion
- 21 May 2019 (actual)
- First posted
- 20 Nov 2017 (actual)
- 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.
Prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up study to compare the clinical outcomes of two trifocal IOLs with different material
Detailed description
This is a prospective, randomised, 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. The patients will either be implanted with the hydrophobic IOL FineVision POD F GF or the hydrophilic IOL FineVision Pod F.
The primary and secondary effectiveness data for visual acuity, contrast sensitivity, halometry, aberrometry, questionnaire outcomes and any adverse events will be collected.
Subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 3 months. Subjects would have the option for unscheduled visits if required medically.
Primary endpoint data will be collected at the 3 months follow up visit. Data analyses will be done after the last patient finished the final examination to support the study publication plan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IOL implantation experimental | Experimental | Device: IOL implantation experimentalhydrophobic, trifocal intraocular lens POD F GF |
| IOL implantation active comparator | Active comparator | Device: IOL implantation active comparatorhydrophilic, trifocal intraocular lens POD F |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- Irregular astigmatism
- Age of patient < 50 years
- Regular corneal astigmatism >1.00 dioptres by an automatic keratometer or biometer or >1.25 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…)
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 |
|---|---|---|
| IOL implantation experimentalImplantation of trifocal IOL POD F GF consisting of hydrophobic material | Device | IOL implantation experimental |
| IOL implantation active comparatorImplantation of trifocal IOL POD F consisting of hydrophilic material | Device | IOL implantation active comparator |
Primary outcome
monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions.
Time frame: 3 months postoperative
The primary study end point is to show statistically equal visual acuity outcomes between both study groups. The primary study endpoint parameter is monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions. UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014
17 secondary outcomes
Manifested refraction - Sphere
Time frame: 3 months postoperative
Manifested refraction - Cylinder
Time frame: 3 months postoperative
Uncorrected Distance Visual Acuity (UDVA)
Time frame: 3 months postoperative
Corrected Distance Visual Acuity (CDVA)
Time frame: 3 months postoperative
Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA)
Time frame: 3 months postoperative
Distance Corrected Intermediate Visual Acuity at 63cm (DCIVA)
Time frame: 3 months postoperative
Distance Corrected Near Visual Acuity at 40cm (DCNVA)
Time frame: 3 months postoperative
Distance Corrected Near Visual Acuity at 25cm (DCNVA)
Time frame: 3 months postoperative
Halometry
Time frame: 3 months postoperative
Contrast Sensitivity
Time frame: 3 months postoperative
Aberrometry - SA
Time frame: 3 months postoperative
Aberrometry - HOA
Time frame: 3 months postoperative
Aberrometry - Tilt
Time frame: 3 months postoperative
OQAS II - OSI
Time frame: 3 months postoperative
OQAS II - MTF
Time frame: 3 months postoperative
OQAS II - Strehl Ratio
Time frame: 3 months postoperative
questionnaire
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.
Francisco Poyales Galan, MD principal investigator
Innova Ocular IOA Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IOL implantation experimental and IOL implantation active comparator in people with Cataract and Lens Opacities, run by Beaver-Visitec International, Inc. at 1 site in Spain.
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 11 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 Spain. 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?
monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions. (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; AzTrials last refreshed its copy on 1 Nov 2026.