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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IOL implantation experimental | Experimental | hydrophobic, trifocal intraocular lens POD L GF with light distribution far > intermediate > near |
|
| IOL implantation active comparator | Active Comparator | hydrophobic, trifocal intraocular lens POD F GF with light distribution far > near > intermediate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IOL implantation experimental | Device | Implantation of trifocal IOL POD F GF consisting of light distribution order: far > intermediate > near |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 months postoperative |
| Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Edward Ang, MD | Asian Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asian Eye Institute | Makati City | 1200 | Philippines |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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| IOL implantation active comparator | Device | Implantation of trifocal IOL POD F GF consisting of light distribution order: far > near > intermediate |
|
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Contrast Sensitivity under photopic and mesopic light conditions | 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. | 3 months postoperative |
| AcuTarget diagnostic device | Measurement of Ocular Scatter Index (OSI) score to evaluate and compare the scattering of the implanted lenses. | 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. | 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. | 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. | 3 months postoperative |