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Completed

NCT Number: NCT03688399

Comparison of Clinical Outcomes POD L GF vs POD F GF (PHY1707)

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases Lens Opacity Presbyopia Refractive Errors

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Semmelweis University - Department of Ophthalmology

Budapest, 1085, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cataractous eyes and/or patients suffering from presbyopia with no ocular 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
  • Complicated surgery

Treatment and study plan

IOL implantation experimental

Device

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

IOL implantation comparator

Device

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

Primary outcomes

  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 outcomes

  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 (monocular)

    Time frame: 6 months postoperative

    Contrast Sensitivity under photopic and mesopic light conditions

  15. Contrast Sensitivity (binocular)

    Time frame: 3 months postoperative

    Contrast Sensitivity under photopic and mesopic light conditions

  16. Questionnaire: Visual Functioning Questionnaire - 25 (VFQ-25, National Eye Institute)

    Time frame: 3 months postoperative

    Patient reported 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. This questionnaire consists of 25 questions. Each answer is scaled between a score of 0 and 100 according to a predefined calculation algorithm, with 100 always being the best possible outcome.

    Additionally subscales are calculated as an average value of several answers belonging to the same set of questions.

    The subscales are:

    • General Health
    • General Vision
    • Ocular Pain
    • Near Activities
    • Distance Activities
    • Social Functioning
    • Mental Health
    • Role Difficulties
    • Dependancy
    • Driving
    • Color Vision
    • Peripheral Vision

  17. Defocus Curve monocular

    Time frame: 1 month postoperative

    To assess the visual acuity for different distances, defocus curves under photopic and mesopic 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.

  18. Defocus Curve binocular

    Time frame: 3 months postoperative

    To assess the visual acuity for different distances, defocus curves under photopic and mesopic 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.

Sponsors and collaborators

Lead sponsor

Beaver-Visitec International, Inc.

Industry

Registry information

Official study title

Clinical Study to Compare Clinical Outcomes of Hydrophobic Trifocal IOLs FineVision POD F GF and FineVision POD L GF After Bilateral Implantation

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 28, 2018
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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