Cataract, Lens Opacities, Presbyopia
Conditions
Keywords
Intraocular Lens, trifocal, hydrophobic
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.
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.
Interventions
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
Sponsors
Beaver-Visitec International, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Cataractous eyes with no comorbidity * Availability, willingness and sufficient cognitive awareness to comply with examination procedures * Signed informed consent
Exclusion criteria
* Age of patient \<40 years * Irregular astigmatism * 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° * Difficulty for cooperation (distance from their home, general health condition) * Acute or chronic disease or illness that would increase risk or confound study results (e.g. diabetes mellitus (with retinopathy), immunocompromised, glaucoma etc…) * Any ocular comorbidity * History of ocular trauma or prior ocular surgery including refractive procedures * Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome) * Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions) * AMD suspicious eyes (determined by OCT)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
| 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. |
Countries
Philippines
Outcome results
None listed