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Visual Performance Intraocular Lens (IOL) MicroPure 1.2.3.

Sponsor
Beaver-Visitec International, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03297372
Collaborator
(none)
121
Enrollment
2
Locations
1
Arm
57.3
Anticipated Duration (Months)
60.5
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: IOL implantation
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
121 participants
Allocation:
N/A
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 :
Oct 23, 2017
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. monocular Corrected Distance Visual Acuity (CDVA) under photopic conditions [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 [2 years postoperative]

    grade of the PCO determined by slitlamp

  2. Uncorrected Distance Visual acuity (UDVA) [6 months postoperative]

    Monocular Uncorrected Distance Visual acuity (UDVA)

  3. Contrast Sensitivity [6 months postoperative]

    Contrast Sensitivity under photopic and mesopic light conditions

  4. Glistening assessment [2 years postoperative]

    Assessment of glistenings by slitlamp determination

Eligibility Criteria

Criteria

Ages Eligible for Study:
45 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Azienda Ospedaliera San Giovanni Addolorata - presidio Britannico Rome Italy 00184
2 Fondazione GB Bietti - IRCCS Rome Italy 00198

Sponsors and Collaborators

  • Beaver-Visitec International, Inc.

Investigators

  • Principal Investigator: Domenico Schiano, MD, Fondazione GB Bietti - IRCCS

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beaver-Visitec International, Inc.
ClinicalTrials.gov Identifier:
NCT03297372
Other Study ID Numbers:
  • PHY1604
First Posted:
Sep 29, 2017
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
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.
Intraocular lens
monofocal
cataract
PhysIOL
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Jul 20, 2022