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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 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 |
|---|---|---|
| Zoltan Nagy, MD | Semmelweis University - Department of Ophthalmology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University - Department of Ophthalmology | Budapest | 1085 | Hungary |
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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 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 (monocular) | Contrast Sensitivity under photopic and mesopic light conditions | 6 months postoperative |
| Contrast Sensitivity (binocular) | Contrast Sensitivity under photopic and mesopic light conditions | 3 months postoperative |
| Questionnaire: Visual Functioning Questionnaire - 25 (VFQ-25, National Eye Institute) | Patient reported 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. This questionnaire consists of 25 questions. Each answer is scaled between a score of 0 and 100 according to a predefined calculation algorithm, with 100 always being the best possible outcome. Additionally subscales are calculated as an average value of several answers belonging to the same set of questions. The subscales are:
| 3 months postoperative |
| Defocus Curve monocular | To assess the visual acuity for different distances, defocus curves under photopic and mesopic 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 and mesopic 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 |