PHY1802: Comparison of Clinical Outcomes POD L GF vs POD F GF in Asian Eyes

Sponsor
Beaver-Visitec International, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03688425
Collaborator
(none)
58
1
2
35.7
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: IOL implantation experimental
  • Device: IOL implantation active comparator
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Study to Compare Clinical Outcomes of Trifocal IOLs FineVision POD L GF and FineVision POD F GF After Bilateral Implantation in Asian Eyes
Actual Study Start Date :
Oct 9, 2018
Actual Primary Completion Date :
Aug 28, 2021
Actual Study Completion Date :
Sep 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: IOL implantation experimental

hydrophobic, trifocal intraocular lens POD L GF with light distribution far > intermediate > near

Device: IOL implantation experimental
Implantation of trifocal IOL POD F GF consisting of light distribution order: far > intermediate > near

Active Comparator: IOL implantation active comparator

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 > near > intermediate

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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)

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. Contrast Sensitivity [3 months postoperative]

    Contrast Sensitivity under photopic and mesopic light conditions

  15. 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.

  16. AcuTarget diagnostic device [3 months postoperative]

    Measurement of Ocular Scatter Index (OSI) score to evaluate and compare the scattering of the implanted lenses.

  17. 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.

  18. 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.

  19. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Asian Eye Institute Makati City Philippines 1200

Sponsors and Collaborators

  • Beaver-Visitec International, Inc.

Investigators

  • Principal Investigator: Robert Edward Ang, MD, Asian Eye Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beaver-Visitec International, Inc.
ClinicalTrials.gov Identifier:
NCT03688425
Other Study ID Numbers:
  • PHY1802
First Posted:
Sep 28, 2018
Last Update Posted:
Jan 11, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Beaver-Visitec International, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2022