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Prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up study to compare the clinical outcomes of two trifocal IOLs with different material
This is a prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up 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 F GF or the hydrophilic IOL FineVision Pod F.
The primary and secondary effectiveness data for visual acuity, contrast sensitivity, halometry, aberrometry, questionnaire outcomes and any adverse events will be collected.
Subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 3 months. Subjects would have the option for unscheduled visits if required medically.
Primary endpoint data will be collected at the 3 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 F GF |
|
| IOL implantation active comparator | Active Comparator | hydrophilic, trifocal intraocular lens POD F |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IOL implantation experimental | Device | Implantation of trifocal IOL POD F GF consisting of hydrophobic material |
|
| Measure | Description | Time Frame |
|---|---|---|
| monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions. | The primary study end point is to show statistically equal visual acuity outcomes between both study groups. The primary study endpoint parameter is monocular 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 | 3 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Manifested refraction - Sphere | The spherical part of the manifested refraction is measured by means of a phoropter. The examination is done according to ISO 11979-7:2014. | 3 months postoperative |
| Manifested refraction - Cylinder |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francisco Poyales Galan, MD | Innova Ocular IOA Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innova Ocular IOA Madrid | Madrid | 28003 | Spain |
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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 consisting of hydrophilic material |
|
The cylindrical part of the manifested refraction is measured by means of a phoropter. Amount of cylinder and cylinder axis will be noted. The examination is done 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) | UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2014. This assessment is done binocularly. | 3 months postoperative |
| Corrected Distance Visual Acuity (CDVA) | 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 and binocularly. | 3 months postoperative |
| Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) | DCIVA is measured with Radner reading charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly. | 3 months postoperative |
| Distance Corrected Intermediate Visual Acuity at 63cm (DCIVA) | DCIVA is measured with ETDRS charts placed in 63cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly. | 3 months postoperative |
| Distance Corrected Near Visual Acuity at 40cm (DCNVA) | DCNVA is measured with Radner reading charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly. | 3 months postoperative |
| Distance Corrected Near Visual Acuity at 25cm (DCNVA) | DCNVA is measured with Radner reading charts placed in 25cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly. | 3 months postoperative |
| Halometry | Halometry outcomes, measurement by halos software v1.0 | 3 months postoperative |
| Contrast Sensitivity | Contrast Sensitivity under photopic and mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision) | 3 months postoperative |
| Aberrometry - SA | Aberrometry outcomes are measured with a standard aberrometer. In this examination, the following values will be evaluated: Spherical aberration | 3 months postoperative |
| Aberrometry - HOA | Aberrometry outcomes are measured with a standard aberrometer. In this examination, the following values will be evaluated: High Order Aberrations | 3 months postoperative |
| Aberrometry - Tilt | Aberrometry outcomes are measured with a standard aberrometer. In this examination, the following values will be evaluated: lens tilt | 3 months postoperative |
| OQAS II - OSI | Outcomes of OQAS II diagnostic device (Ocular Scatter Index) | 3 months postoperative |
| OQAS II - MTF | Outcomes of OQAS II diagnostic device (Modular Transfer Function) | 3 months postoperative |
| OQAS II - Strehl Ratio | Outcomes of OQAS II diagnostic device (Strehl Ratio) | 3 months postoperative |
| questionnaire | 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. The scoring and evaluation of the questionnaire will be done according to the official guidelines and manual provided by National Eye Institute | 3 months postoperative |