PHY1802: Comparison of Clinical Outcomes POD L GF vs POD F GF in Asian Eyes
Study Details
Study Description
Brief 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. 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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: IOL implantation experimental hydrophobic, trifocal intraocular lens POD L GF with light distribution far > intermediate > near |
Device: IOL implantation experimental
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 |
Device: IOL implantation active comparator
Implantation of trifocal IOL POD F GF consisting of light distribution order: far > near > intermediate
|
Outcome Measures
Primary Outcome Measures
- monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions. [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.
Secondary Outcome Measures
- Manifested refraction [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)
- Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions [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.
- Uncorrected Distance Visual Acuity (UDVA) under mesopic light conditions [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.
- Corrected Distance Visual Acuity (CDVA) under photopic light conditions [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.
- Corrected Distance Visual Acuity (CDVA) under mesopic light conditions [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.
- Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) under photopic light conditions [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.
- Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) under mesopic light conditions [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.
- Uncorrected Intermediate Visual Acuity at 70cm (UIVA) under photopic light conditions [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.
- Uncorrected Intermediate Visual Acuity at 70cm (UIVA) under mesopic light conditions [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.
- Distance Corrected Near Visual Acuity at 35cm (DCNVA) under photopic light conditions [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.
- Distance Corrected Near Visual Acuity at 35cm (DCNVA) under mesopic light conditions [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.
- Uncorrected Near Visual Acuity at 35cm (UNVA) under photopic light conditions [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.
- Uncorrected Near Visual Acuity at 35cm (UNVA) under mesopic light conditions [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.
- Contrast Sensitivity [3 months postoperative]
Contrast Sensitivity under photopic and mesopic light conditions
- Aberrometry [3 months postoperative]
Aberrometry outcomes are measured with a standard aberrometer. The following values will be evaluated in this study: Spherical aberrations, high order aberrations, lens tilt.
- AcuTarget diagnostic device [3 months postoperative]
Measurement of Ocular Scatter Index (OSI) score to evaluate and compare the scattering of the implanted lenses.
- Questionnaire VFQ-25 (National Eye Institute) [3 months postoperative]
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.
- Defocus Curve monocular [1 month 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 monocularly.
- Defocus Curve binocular [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Cataractous eyes with no comorbidity
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Availability, willingness and sufficient cognitive awareness to comply with examination procedures
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Signed informed consent
Exclusion Criteria:
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Age of patient <40 years
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Irregular astigmatism
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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°
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Difficulty for cooperation (distance from their home, general health condition)
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Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…)
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Any ocular comorbidity
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History of ocular trauma or prior ocular surgery including refractive procedures
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Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
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Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
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AMD suspicious eyes (determined by OCT)
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Asian Eye Institute | Makati City | Philippines | 1200 |
Sponsors and Collaborators
- Beaver-Visitec International, Inc.
Investigators
- Principal Investigator: Robert Edward Ang, MD, Asian Eye Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PHY1802