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Clinical Study to Compare Visual Performance of Two Trifocal IOLs (PHY1702)

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ClinicalTrials.gov Identifier: NCT03347981
Recruitment Status : Recruiting
First Posted : November 20, 2017
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Physiol

Brief Summary:
Prospective, randomised, controlled, single-surgeon, single-center post-market clinical follow up study to compare the clinical outcomes of two trifocal IOLs with different material

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 post-market clinical follow up 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 F GF or the hydrophilic IOL FineVision Pod F.

The primary and secondary effectiveness data for visual acuity, contrast sensitivity, halometry, aberrometry, questionnaire outcomes and any adverse events will be collected.

Subjects participating in the trial will attend a total of 10 study visits (1 preoperative, 2 operative and 7 postoperative) over a period of 3 months. Subjects would have the option for unscheduled visits if required medically.

Primary endpoint data will be collected at the 3 months follow up visit. Data analyses will be done after the last patient finished the final examination to support the study publication plan.


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 Visual Performance of Two Trifocal IOLs With Different Material (Hydrophobic and Hydrophilic)
Actual Study Start Date : October 2, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Arm Intervention/treatment
Experimental: IOL implantation experimental
hydrophobic, trifocal intraocular lens POD F GF
Device: IOL implantation experimental
Implantation of trifocal IOL POD F GF consisting of hydrophobic material

Active Comparator: IOL implantation active comparator
hydrophilic, trifocal intraocular lens POD F
Device: IOL implantation active comparator
Implantation of trifocal IOL POD F consisting of hydrophilic material




Primary Outcome Measures :
  1. monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions. [ Time Frame: 3 months postoperative ]
    The primary study end point is to show statistically equal visual acuity outcomes between both study groups. The primary study endpoint parameter is monocular 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


Secondary Outcome Measures :
  1. Manifested refraction - Sphere [ Time Frame: 3 months postoperative ]
    The spherical part of the manifested refraction is measured by means of a phoropter. The examination is done according to ISO 11979-7:2014.

  2. Manifested refraction - Cylinder [ Time Frame: 3 months postoperative ]
    The cylindrical part of the manifested refraction is measured by means of a phoropter. Amount of cylinder and cylinder axis will be noted. The examination is done according to ISO 11979-7:2014. This data will also be used to calculate the manifested refractive spherical equivalent (MRSE)

  3. Uncorrected Distance Visual Acuity (UDVA) [ 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 binocularly.

  4. Corrected Distance Visual Acuity (CDVA) [ 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 monocularly and binocularly.

  5. Distance Corrected Intermediate Visual Acuity at 80cm (DCIVA) [ Time Frame: 3 months postoperative ]
    DCIVA is measured with Radner reading charts placed in 80cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.

  6. Distance Corrected Intermediate Visual Acuity at 63cm (DCIVA) [ Time Frame: 3 months postoperative ]
    DCIVA is measured with ETDRS charts placed in 63cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.

  7. Distance Corrected Near Visual Acuity at 40cm (DCNVA) [ Time Frame: 3 months postoperative ]
    DCNVA is measured with Radner reading charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.

  8. Distance Corrected Near Visual Acuity at 25cm (DCNVA) [ Time Frame: 3 months postoperative ]
    DCNVA is measured with Radner reading charts placed in 25cm distance with corrective glasses for far distance according to ISO 11979-7:2014. This assessment is done monocularly and binocularly.

  9. Halometry [ Time Frame: 3 months postoperative ]
    Halometry outcomes, measurement by halos software v1.0

  10. Contrast Sensitivity [ Time Frame: 3 months postoperative ]
    Contrast Sensitivity under photopic and mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)

  11. Aberrometry - SA [ Time Frame: 3 months postoperative ]
    Aberrometry outcomes are measured with a standard aberrometer. In this examination, the following values will be evaluated: Spherical aberration

  12. Aberrometry - HOA [ Time Frame: 3 months postoperative ]
    Aberrometry outcomes are measured with a standard aberrometer. In this examination, the following values will be evaluated: High Order Aberrations

  13. Aberrometry - Tilt [ Time Frame: 3 months postoperative ]
    Aberrometry outcomes are measured with a standard aberrometer. In this examination, the following values will be evaluated: lens tilt

  14. OQAS II - OSI [ Time Frame: 3 months postoperative ]
    Outcomes of OQAS II diagnostic device (Ocular Scatter Index)

  15. OQAS II - MTF [ Time Frame: 3 months postoperative ]
    Outcomes of OQAS II diagnostic device (Modular Transfer Function)

  16. OQAS II - Strehl Ratio [ Time Frame: 3 months postoperative ]
    Outcomes of OQAS II diagnostic device (Strehl Ratio)

  17. questionnaire [ 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. The scoring and evaluation of the questionnaire will be done according to the official guidelines and manual provided by National Eye Institute



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Cataractous eyes with no comorbidity
  • Spontaneously emitting the desire for spectacle independence after surgery and with realistic expectation.
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures
  • Signed informed consent

Exclusion Criteria:

  • Irregular astigmatism
  • Age of patient < 50 years
  • Regular corneal astigmatism >1.00 dioptres by an automatic keratometer or biometer or >1.25 dioptres if the steep axis of cylinder is between 90° and 120° in one or both eyes
  • 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)
  • Complicated surgery

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): NCT03347981


Contacts
Contact: Jochen Kandulla, PhD +49 157 862 75281 j.kandulla@physiol.be
Contact: Sally Lamborelle +32 4 361 45 49 s.lamborelle@physiol.be

Locations
Spain
Innova Ocular IOA Madrid Recruiting
Madrid, Spain, 28003
Contact: Nuria Gazon Jimenez, PhD    +34 91 535 35 70    ngarzon@ioamadrid.com   
Principal Investigator: Francisco Poyals Galan, MD         
Sub-Investigator: Nuria Gazon Jimenez, PhD         
Sub-Investigator: Pilar Garrido Fernández         
Sub-Investigator: Israel López-Brea         
Sponsors and Collaborators
Physiol
Investigators
Principal Investigator: Francisco Poyales Galan, MD Innova Ocular IOA Madrid

Responsible Party: Physiol
ClinicalTrials.gov Identifier: NCT03347981     History of Changes
Other Study ID Numbers: PHY1702
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
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 Physiol:
Intraocular Lens
trifocal
hydrophobic
hydrophilic

Additional relevant MeSH terms:
Cataract
Presbyopia
Lens Diseases
Eye Diseases
Refractive Errors