CataractPHY1802NCT03688425
Comparison of Clinical Outcomes POD L GF vs POD F GF in Asian Eyes
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 Philippines.
Trial summary
Prospective, randomised, controlled, single-surgeon, single-center clinical study to compare the clinical outcomes of two trifocal IOLs differing in the dominance of additional power. Read more about this study
- Who is it for?
- Ages 40 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
- 58 participants
- Where
- 1 sitePhilippines
- Study dates
- 9 Oct 2018to 30 Sep 2021
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cataractous eyes with no comorbidity
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- Signed informed consent
Who cannot join
- Age of patient <40 years
- Irregular astigmatism
- Regular corneal astigmatism >0.75 dioptres by an automatic keratometer or biometer or >1.0 dioptres if the steep axis of cylinder is between 90° and 120°
- 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)
- AMD suspicious eyes (determined by OCT)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Compare Clinical Outcomes of Trifocal IOLs FineVision POD L GF and FineVision POD F GF After Bilateral Implantation in Asian Eyes
Prospective, randomised, controlled, single-surgeon, single-center clinical study to compare the clinical outcomes of two trifocal IOLs differing in the dominance of additional power. The investigational device POD L GF shows dominance for the intermediate addition (+1.75 D), whereas the control device POD F GF shows dominance for the near addition (+3.5 D). Implantation of the IOLs is bilaterally.
Read the detailed description
This is a prospective, randomised, controlled, single-surgeon, single-center clinical 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 L GF or the hydrophobic IOL FineVision POD F GF (both lenses: (PhysIOL, Liège, Belgium).
The devices under investigation (FineVision POD L GF and POD F GF) are trifocal glistening-free acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. Both consist of the same hydrophobic material. The main difference between the lenses is the dominance of additional power. The investigational device POD L GF shows dominance for the intermediate addition (+1.75 D), whereas the control device POD F GF shows dominance for the near addition (+3.5 D). The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.
Subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 6 months. Subjects would have the option for unscheduled visits if required medically.
Primary and secondary endpoint data will be collected at the 6 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
- 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 light distribution order: far > intermediate > near
IOL implantation active comparatorDevice
Implantation of trifocal IOL POD F GF consisting of light distribution order: far > near > intermediate
| Study group | Role | What they receive |
|---|---|---|
| IOL implantation experimental | Experimental | hydrophobic, trifocal intraocular lens POD L GF with light distribution far > intermediate > near Receives: Device: IOL implantation experimental |
| IOL implantation active comparator | Active comparator | hydrophobic, trifocal intraocular lens POD F GF with light distribution far > near > intermediate Receives: Device: IOL implantation active comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions.
No statistically significant difference between the two study groups on monocular CDVA at 3 months follow up visit. A significance level of 0.05 or lower (p < 0.05) will be considered statistically significant. CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014.
Measured: 3 months postoperative
Secondary outcomes (19)
Manifested refraction
The manifested refraction is measured by means of a phoropter. The data contains values for sphere, cylinder and axis of cylinder 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) under photopic light conditions
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly under photopic light conditions.
Measured: 3 months postoperative
Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions
UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic light conditions.
Measured: 6 months postoperative
Corrected Distance Visual Acuity (CDVA) under photopic light conditions
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 binocularly under photopic light conditions.
Measured: 3 months postoperative
Corrected Distance Visual Acuity (CDVA) under mesopic light conditions
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 under mesopic light conditions.
Measured: 6 months postoperative
Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) under photopic light conditions
DCIVA is measured with ETDRS charts placed in 70cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly under photopic light conditions.
Measured: 3 months postoperative
Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) under mesopic light conditions
DCIVA is measured with ETDRS charts placed in 70cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic light conditions.
Measured: 6 months postoperative
Uncorrected Intermediate Visual Acuity at 70cm (UIVA) under photopic light conditions
UIVA is measured with ETDRS charts placed in 70cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly and binocularly under photopic light conditions.
Measured: 3 months postoperative
Uncorrected Intermediate Visual Acuity at 70cm (UIVA) under mesopic light conditions
UIVA is measured with ETDRS charts placed in 70cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly under mesopic light conditions.
Measured: 6 months postoperative
Distance Corrected Near Visual Acuity at 35cm (DCNVA) under photopic light conditions
DCNVA is measured with ETDRS charts placed in 35cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly under photopic light conditions.
Measured: 3 months postoperative
Distance Corrected Near Visual Acuity at 35cm (DCNVA) under mesopic light conditions
DCNVA is measured with ETDRS charts placed in 35cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly under mesopic light conditions.
Measured: 6 months postoperative
Uncorrected Near Visual Acuity at 35cm (UNVA) under photopic light conditions
UNVA is measured with ETDRS charts placed in 35cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly and binocularly under photopic light conditions.
Measured: 3 months postoperative
Uncorrected Near Visual Acuity at 35cm (UNVA) under mesopic light conditions
UNVA is measured with ETDRS charts placed in 35cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2014. This assessment is done monocularly under mesopic light conditions.
Measured: 6 months postoperative
Contrast Sensitivity
Contrast Sensitivity under photopic and mesopic light conditions
Measured: 3 months postoperative
Aberrometry
Aberrometry outcomes are measured with a standard aberrometer. The following values will be evaluated in this study: Spherical aberrations, high order aberrations, lens tilt.
Measured: 3 months postoperative
AcuTarget diagnostic device
Measurement of Ocular Scatter Index (OSI) score to evaluate and compare the scattering of the implanted lenses.
Measured: 3 months postoperative
Questionnaire VFQ-25 (National Eye Institute)
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.
Measured: 3 months postoperative
Defocus Curve monocular
To assess the visual acuity for different distances, defocus curves under photopic light conditions are measured. This test is performed with best distance corrected refraction and spherical additions ranging from -5.0 D to +1.5 D. This examination is performed monocularly.
Measured: 1 month postoperative
Defocus Curve binocular
To assess the visual acuity for different distances, defocus curves under photopic light conditions are measured. This test is performed with best distance corrected refraction and spherical additions ranging from -5.0 D to +1.5 D. This examination is performed binocularly.
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 posted28 Sep 2018
- Study start9 Oct 2018
- Primary completion28 Aug 2021
- Study completion30 Sep 2021
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
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beaver-Visitec International, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Edward Ang, MD, Principal investigator, Asian Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688425
- Sponsor's protocol ID
- PHY1802
- Acronym
- PHY1802
- Status last verified
- Jan 2022
- First submitted
- 26 Sep 2018
- Last updated
- 11 Jan 2022
- 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 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Compare Clinical Outcomes of Trifocal IOLs FineVision POD L GF and FineVision POD F GF After Bilateral Implantation in Asian Eyes
- ClinicalTrials.gov ID
- NCT03688425
- Acronym / sponsor ID
- PHY1802 / PHY1802
- Conditions
- Cataract, Lens Opacities, Presbyopia
- Keywords
- Intraocular Lens, trifocal, hydrophobic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Beaver-Visitec International, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 28 Aug 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 28 Sep 2018 (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 clinical study to compare the clinical outcomes of two trifocal IOLs differing in the dominance of additional power. The investigational device POD L GF shows dominance for the intermediate addition (+1.75 D), whereas the control device POD F GF shows dominance for the near addition (+3.5 D). Implantation of the IOLs is bilaterally.
Detailed description
This is a prospective, randomised, controlled, single-surgeon, single-center clinical 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 L GF or the hydrophobic IOL FineVision POD F GF (both lenses: (PhysIOL, Liège, Belgium).
The devices under investigation (FineVision POD L GF and POD F GF) are trifocal glistening-free acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. Both consist of the same hydrophobic material. The main difference between the lenses is the dominance of additional power. The investigational device POD L GF shows dominance for the intermediate addition (+1.75 D), whereas the control device POD F GF shows dominance for the near addition (+3.5 D). The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.
Subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 6 months. Subjects would have the option for unscheduled visits if required medically.
Primary and secondary endpoint data will be collected at the 6 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 L GF with light distribution far > intermediate > near |
| IOL implantation active comparator | Active comparator | Device: IOL implantation active comparatorhydrophobic, trifocal intraocular lens POD F GF with light distribution far > near > intermediate |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cataractous eyes with no comorbidity
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- Signed informed consent
Key exclusion criteria (10 listed)
- Age of patient <40 years
- Irregular astigmatism
- Regular corneal astigmatism >0.75 dioptres by an automatic keratometer or biometer or >1.0 dioptres if the steep axis of cylinder is between 90° and 120°
- 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 light distribution order: far > intermediate > near | Device | IOL implantation experimental |
| IOL implantation active comparatorImplantation of trifocal IOL POD F GF consisting of light distribution order: far > near > intermediate | Device | IOL implantation active comparator |
Primary outcome
monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions.
Time frame: 3 months postoperative
No statistically significant difference between the two study groups on monocular CDVA at 3 months follow up visit. A significance level of 0.05 or lower (p < 0.05) will be considered statistically significant. CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2014.
19 secondary outcomes
Manifested refraction
Time frame: 3 months postoperative
Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
Time frame: 3 months postoperative
Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions
Time frame: 6 months postoperative
Corrected Distance Visual Acuity (CDVA) under photopic light conditions
Time frame: 3 months postoperative
Corrected Distance Visual Acuity (CDVA) under mesopic light conditions
Time frame: 6 months postoperative
Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) under photopic light conditions
Time frame: 3 months postoperative
Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) under mesopic light conditions
Time frame: 6 months postoperative
Uncorrected Intermediate Visual Acuity at 70cm (UIVA) under photopic light conditions
Time frame: 3 months postoperative
Uncorrected Intermediate Visual Acuity at 70cm (UIVA) under mesopic light conditions
Time frame: 6 months postoperative
Distance Corrected Near Visual Acuity at 35cm (DCNVA) under photopic light conditions
Time frame: 3 months postoperative
Distance Corrected Near Visual Acuity at 35cm (DCNVA) under mesopic light conditions
Time frame: 6 months postoperative
Uncorrected Near Visual Acuity at 35cm (UNVA) under photopic light conditions
Time frame: 3 months postoperative
Uncorrected Near Visual Acuity at 35cm (UNVA) under mesopic light conditions
Time frame: 6 months postoperative
Contrast Sensitivity
Time frame: 3 months postoperative
Aberrometry
Time frame: 3 months postoperative
AcuTarget diagnostic device
Time frame: 3 months postoperative
Questionnaire VFQ-25 (National Eye Institute)
Time frame: 3 months postoperative
Defocus Curve monocular
Time frame: 1 month postoperative
Defocus Curve binocular
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 11 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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.
Robert Edward Ang, MD principal investigator
Asian Eye Institute
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 Philippines.
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 3 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 11 Jan 2022. 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 Philippines. 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 Best Corrected Distance Visual Acuity (CDVA) 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 11 Jan 2022.