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Trial record 34 of 39 for:    Recruiting, Not yet recruiting, Available Studies | "Lenses, Intraocular"

Comparison of Clinical Outcomes on Trifocal IOLs FineVision POD F GF and FineVision POD F in Asian Eyes (PHY1706)

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ClinicalTrials.gov Identifier: NCT03306355
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : December 21, 2017
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 with different material (hydrophobic and hydrophilic) from the same manufacturer. 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 F GF or the hydrophilic IOL FineVision POD F (both lenses: (PhysIOL, Liège, Belgium).

The devices under investigation (FineVision POD F GF and POD F) are trifocal glistening-free acrylic intraocular lenses (IOLs) manufactured by the sponsor of this study PhysIOL sa/nv. The main difference between the lenses is the material (hydrophobic and hydrophilic). 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 9 study visits (1 preoperative, 2 operative and 6 postoperative) over a period of 3 months. Subjects would have the option for unscheduled visits if required medically.

Primary and secondary 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 Clinical Outcomes of IOLs FineVision POD F GF (Hydrophobic) and FineVision POD F (Hydrophilic) After Bilateral Implantation in Asian Eyes
Actual Study Start Date : December 4, 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 ]
    No statistically significant difference between the two study groups on monocular UDVA at 3 months follow up visit. A significance level of 0.05 or lower (p < 0.05) will be considered statistically significant. UDVA is measured with ETDRS charts placed in 4m distance 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) [ 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.

  3. 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.

  4. Distance Corrected Intermediate Visual Acuity at 70cm (DCIVA) [ 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.

  5. Uncorrected Intermediate Visual Acuity at 70cm (UIVA) [ 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.

  6. Distance Corrected Near Visual Acuity at 35cm (DCNVA) [ 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.

  7. Uncorrected Near Visual Acuity at 35cm (UNVA) [ 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.

  8. Contrast Sensitivity [ Time Frame: 3 months postoperative ]
    Contrast Sensitivity under photopic and mesopic light conditions

  9. 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.

  10. 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.

  11. 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.

  12. Defocus Curve [ 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 monocularly and binocularly.



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Ages Eligible for Study:   45 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:

  • Unrealistic expectation
  • Age of patient <45 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)
  • 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): NCT03306355


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
Philippines
Asian Eye Institute Recruiting
Makati City, Philippines, 1200
Contact: Robert Edward Ang, MD    +63 2 898 2020 ext 821    RTAng@asianeyeinstitute.com   
Principal Investigator: Robert Edward Ang, MD         
Sponsors and Collaborators
Physiol
Investigators
Principal Investigator: Robert Edward Ang, MD Asian Eye Institute

Responsible Party: Physiol
ClinicalTrials.gov Identifier: NCT03306355     History of Changes
Other Study ID Numbers: PHY 1706
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 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