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Completed

NCT Number: NCT03347981

Clinical Study to Compare Visual Performance of Two Trifocal IOLs

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

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Key information

Conditions

Cataract Eye Diseases Lens Diseases Lens Opacities Presbyopia Refractive Errors

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Innova Ocular IOA Madrid

Madrid, 28003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

IOL implantation experimental

Device

Implantation of trifocal IOL POD F GF consisting of hydrophobic material

IOL implantation active comparator

Device

Implantation of trifocal IOL POD F consisting of hydrophilic material

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Beaver-Visitec International, Inc.

Industry

Registry information

Official study title

Clinical Study to Compare Visual Performance of Two Trifocal IOLs With Different Material (Hydrophobic and Hydrophilic)

Acronym: PHY1702

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 20, 2017
Registry last updated
May 6, 2021

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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