- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03688425
Comparison of Clinical Outcomes POD L GF vs POD F GF in Asian Eyes (PHY1802)
Clinical Study to Compare Clinical Outcomes of Trifocal IOLs FineVision POD L GF and FineVision POD F GF After Bilateral Implantation in Asian Eyes
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Makati City, Philippines, 1200
- Asian Eye Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Cataractous eyes with no comorbidity
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures
- Signed informed consent
Exclusion Criteria:
- 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
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IOL implantation experimental
hydrophobic, trifocal intraocular lens POD L GF with light distribution far > intermediate > near
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Implantation of trifocal IOL POD F GF consisting of light distribution order: far > intermediate > near
|
Active Comparator: IOL implantation active comparator
hydrophobic, trifocal intraocular lens POD F GF with light distribution far > near > intermediate
|
Implantation of trifocal IOL POD F GF consisting of light distribution order: far > near > intermediate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Manifested refraction
Time Frame: 3 months postoperative
|
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)
|
3 months postoperative
|
Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
Time Frame: 3 months postoperative
|
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.
|
3 months postoperative
|
Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions
Time Frame: 6 months postoperative
|
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.
|
6 months postoperative
|
Corrected Distance Visual Acuity (CDVA) under photopic light conditions
Time Frame: 3 months postoperative
|
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.
|
3 months postoperative
|
Corrected Distance Visual Acuity (CDVA) under mesopic light conditions
Time Frame: 6 months postoperative
|
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.
|
6 months postoperative
|
Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) under photopic light conditions
Time Frame: 3 months postoperative
|
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.
|
3 months postoperative
|
Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) under mesopic light conditions
Time Frame: 6 months postoperative
|
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.
|
6 months postoperative
|
Uncorrected Intermediate Visual Acuity at 70cm (UIVA) under photopic light conditions
Time Frame: 3 months postoperative
|
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.
|
3 months postoperative
|
Uncorrected Intermediate Visual Acuity at 70cm (UIVA) under mesopic light conditions
Time Frame: 6 months postoperative
|
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.
|
6 months postoperative
|
Distance Corrected Near Visual Acuity at 35cm (DCNVA) under photopic light conditions
Time Frame: 3 months postoperative
|
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.
|
3 months postoperative
|
Distance Corrected Near Visual Acuity at 35cm (DCNVA) under mesopic light conditions
Time Frame: 6 months postoperative
|
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.
|
6 months postoperative
|
Uncorrected Near Visual Acuity at 35cm (UNVA) under photopic light conditions
Time Frame: 3 months postoperative
|
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.
|
3 months postoperative
|
Uncorrected Near Visual Acuity at 35cm (UNVA) under mesopic light conditions
Time Frame: 6 months postoperative
|
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.
|
6 months postoperative
|
Contrast Sensitivity
Time Frame: 3 months postoperative
|
Contrast Sensitivity under photopic and mesopic light conditions
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3 months postoperative
|
Aberrometry
Time Frame: 3 months postoperative
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Aberrometry outcomes are measured with a standard aberrometer.
The following values will be evaluated in this study: Spherical aberrations, high order aberrations, lens tilt.
|
3 months postoperative
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AcuTarget diagnostic device
Time Frame: 3 months postoperative
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Measurement of Ocular Scatter Index (OSI) score to evaluate and compare the scattering of the implanted lenses.
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3 months postoperative
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Questionnaire VFQ-25 (National Eye Institute)
Time Frame: 3 months postoperative
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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.
|
3 months postoperative
|
Defocus Curve monocular
Time Frame: 1 month postoperative
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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.
|
1 month postoperative
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Defocus Curve binocular
Time Frame: 3 months postoperative
|
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.
|
3 months postoperative
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHY1802
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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