PHY1702: Clinical Study to Compare Visual Performance of Two Trifocal IOLs

Sponsor
Beaver-Visitec International, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03347981
Collaborator
(none)
53
Enrollment
1
Location
2
Arms
19.6
Actual Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • Device: IOL implantation experimental
  • Device: IOL implantation active comparator
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
53 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 :
Oct 2, 2017
Actual Primary Completion Date :
May 21, 2019
Actual Study Completion Date :
May 21, 2019

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions. [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 [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 [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) [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) [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) [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) [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) [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) [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 [3 months postoperative]

    Halometry outcomes, measurement by halos software v1.0

  10. Contrast Sensitivity [3 months postoperative]

    Contrast Sensitivity under photopic and mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision)

  11. Aberrometry - SA [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 [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 [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 [3 months postoperative]

    Outcomes of OQAS II diagnostic device (Ocular Scatter Index)

  15. OQAS II - MTF [3 months postoperative]

    Outcomes of OQAS II diagnostic device (Modular Transfer Function)

  16. OQAS II - Strehl Ratio [3 months postoperative]

    Outcomes of OQAS II diagnostic device (Strehl Ratio)

  17. questionnaire [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Innova Ocular IOA MadridMadridSpain28003

Sponsors and Collaborators

  • Beaver-Visitec International, Inc.

Investigators

  • Principal Investigator: Francisco Poyales Galan, MD, Innova Ocular IOA Madrid

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beaver-Visitec International, Inc.
ClinicalTrials.gov Identifier:
NCT03347981
Other Study ID Numbers:
  • PHY1702
First Posted:
Nov 20, 2017
Last Update Posted:
May 6, 2021
Last Verified:
May 1, 2021
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 May 6, 2021