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

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ClinicalTrials.gov Identifier: NCT03688425
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Physiol

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
Cataract Lens Opacities Presbyopia Device: IOL implantation experimental Device: IOL implantation active comparator Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 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 : October 9, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

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




Primary Outcome Measures :
  1. monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 months postoperative ]
    Contrast Sensitivity under photopic and mesopic light conditions

  15. Aberrometry [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03688425


Contacts
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Contact: Jochen Kandulla, PhD +49 157 862 75281 j.kandulla@physiol.be
Contact: Christophe Pagnoulle, PhD +32 4 361 42 64 c.pagnoulle@physiol.be

Locations
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Philippines
Asian Eye Institute Recruiting
Makati City, Philippines, 1200
Contact: Gino Antonio C. Lagrosa    +63 2 898 2020 ext 109    gclagrosa@asianeyeinstitute.com   
Principal Investigator: Robert Edward Ang, MD         
Sponsors and Collaborators
Physiol
Investigators
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Principal Investigator: Robert Edward Ang, MD Asian Eye Institute

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Responsible Party: Physiol
ClinicalTrials.gov Identifier: NCT03688425     History of Changes
Other Study ID Numbers: PHY1802
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Physiol:
Intraocular Lens
trifocal
hydrophobic
Additional relevant MeSH terms:
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Cataract
Presbyopia
Lens Diseases
Eye Diseases
Refractive Errors