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Visual Performance Intraocular Lens (IOL) MicroPure 1.2.3.

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ClinicalTrials.gov Identifier: NCT03297372
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Physiol

Brief Summary:
The clinical investigation is a post-market clinical follow up study whereby patients undergoing routine cataract surgery will have monolateral implantation of a commercially available, CE approved monofocal intraocular lens MicroPure 1.2.3. (PhysIOL, Liège, Belgium).

Condition or disease Intervention/treatment Phase
Cataract Lens Opacities Device: IOL implantation Not Applicable

Detailed Description:

The examinations consist of visual acuity data, contrast sensitivity exams, slitlamp examinations and posterior capsule opacification (PCO) grading.

Follow up will be up to 24 months postoperative.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study to Investigate Visual Performance of Hydrophobic Monofocal IOL: MicroPure 1.2.3.
Actual Study Start Date : October 23, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: IOL Implantation experimental
Implantation of Micropure 1.2.3. in one of the eyes of the study subject
Device: IOL implantation
Implantation of monofocal IOL Micropure 1.2.3




Primary Outcome Measures :
  1. monocular Corrected Distance Visual Acuity (CDVA) under photopic conditions [ Time Frame: 6 months postoperative ]
    The primary study end point is to show statistically equal visual acuity outcomes on monocular Corrected Distance Visual Acuity (CDVA) under photopic conditions compared to literature data on a monofocal hydrophobic IOL (Alcon - Acrysof SN60AT).


Secondary Outcome Measures :
  1. Posterior capsule opacification (PCO) grading [ Time Frame: 2 years postoperative ]
    grade of the PCO determined by slitlamp

  2. Uncorrected Distance Visual acuity (UDVA) [ Time Frame: 6 months postoperative ]
    Monocular Uncorrected Distance Visual acuity (UDVA)

  3. Contrast Sensitivity [ Time Frame: 6 months postoperative ]
    Contrast Sensitivity under photopic and mesopic light conditions

  4. Glistening assessment [ Time Frame: 2 years postoperative ]
    Assessment of glistenings by slitlamp determination



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cataractous eyes with no comorbidity
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures
  • Signed informed consent

Exclusion Criteria:

  • Irregular astigmatism
  • Age of patient < 45 years
  • Regular corneal astigmatism > 0.75 D on study eye as measured by an automatic keratometer (regularity determined by the topography of the keratometry)
  • 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)
  • 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): NCT03297372


Contacts
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Contact: Jochen Kandulla, PhD +49 157 862 75 281 j.kandulla@physiol.be
Contact: Sally Lamborelle +32 4 361 45 49 s.lamborelle@physiol.be

Locations
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Italy
Azienda Ospedaliera San Giovanni Addolorata - presidio Britannico Recruiting
Rome, Italy, 00184
Contact: Augusto Pocobelli, MD    +39 6 77052950    apocobelli@hsangiovanni.roma.it   
Principal Investigator: Augusto Pocobelli, MD         
Fondazione GB Bietti - IRCCS Recruiting
Rome, Italy, 00198
Contact: Domenico Schiano, MD    +39 6 85356727    do.schiano@gmail.com   
Principal Investigator: Domenico Schiano, MD         
Sponsors and Collaborators
Physiol
Investigators
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Principal Investigator: Domenico Schiano, MD Fondazione GB Bietti - IRCCS

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Responsible Party: Physiol
ClinicalTrials.gov Identifier: NCT03297372     History of Changes
Other Study ID Numbers: PHY1604
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Physiol:
Intraocular lens
monofocal
cataract
PhysIOL

Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases