An interventional study of IOL implantation experimental and IOL implantation active comparator in Cataract, Lens Opacities and Presbyopia, sponsored by Beaver-Visitec International, Inc.. Completed at 1 site in Philippines. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-11.
Sponsored by Beaver-Visitec International, Inc. · Not applicable, Interventional, and Treatment
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.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 58 is below the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Beaver-Visitec International, Inc. is the lead sponsor of 36 studies on the registry; none are open to participants now.
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Exclusion Criteria:
hydrophobic, trifocal intraocular lens POD L GF with light distribution far \> intermediate \> near
Device: IOL implantation experimental
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 \> intermediate \> near
Implantation of trifocal IOL POD F GF consisting of light distribution order: far \> near \> intermediate
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.
Time frame: 3 months postoperative
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)
Time frame: 3 months postoperative
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. This assessment is done monocularly and binocularly under photopic light conditions.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months postoperative
Contrast Sensitivity
Contrast Sensitivity under photopic and mesopic light conditions
Time frame: 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.
Time frame: 3 months postoperative
AcuTarget diagnostic device
Measurement of Ocular Scatter Index (OSI) score to evaluate and compare the scattering of the implanted lenses.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months postoperative
Plan to share: No
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Beaver-Visitec International, Inc.