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Visual Performance Intraocular Lens (IOL) MicroPure 1.2.3.

Primary Purpose

Cataract, Lens Opacities

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
IOL implantation
Sponsored by
Beaver-Visitec International, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Intraocular lens, monofocal, cataract, PhysIOL

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Azienda Ospedaliera San Giovanni Addolorata - presidio Britannico
  • Fondazione GB Bietti - IRCCS

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IOL Implantation experimental

Arm Description

Implantation of Micropure 1.2.3. in one of the eyes of the study subject

Outcomes

Primary Outcome Measures

monocular Corrected Distance Visual Acuity (CDVA) under photopic conditions
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

Posterior capsule opacification (PCO) grading
grade of the PCO determined by slitlamp
Uncorrected Distance Visual acuity (UDVA)
Monocular Uncorrected Distance Visual acuity (UDVA)
Contrast Sensitivity
Contrast Sensitivity under photopic and mesopic light conditions
Glistening assessment
Assessment of glistenings by slitlamp determination

Full Information

First Posted
September 26, 2017
Last Updated
October 27, 2022
Sponsor
Beaver-Visitec International, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03297372
Brief Title
Visual Performance Intraocular Lens (IOL) MicroPure 1.2.3.
Official Title
Clinical Study to Investigate Visual Performance of Hydrophobic Monofocal IOL: MicroPure 1.2.3.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 23, 2017 (Actual)
Primary Completion Date
September 8, 2022 (Actual)
Study Completion Date
September 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beaver-Visitec International, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Lens Opacities
Keywords
Intraocular lens, monofocal, cataract, PhysIOL

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IOL Implantation experimental
Arm Type
Experimental
Arm Description
Implantation of Micropure 1.2.3. in one of the eyes of the study subject
Intervention Type
Device
Intervention Name(s)
IOL implantation
Intervention Description
Implantation of monofocal IOL Micropure 1.2.3
Primary Outcome Measure Information:
Title
monocular Corrected Distance Visual Acuity (CDVA) under photopic conditions
Description
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).
Time Frame
6 months postoperative
Secondary Outcome Measure Information:
Title
Posterior capsule opacification (PCO) grading
Description
grade of the PCO determined by slitlamp
Time Frame
2 years postoperative
Title
Uncorrected Distance Visual acuity (UDVA)
Description
Monocular Uncorrected Distance Visual acuity (UDVA)
Time Frame
6 months postoperative
Title
Contrast Sensitivity
Description
Contrast Sensitivity under photopic and mesopic light conditions
Time Frame
6 months postoperative
Title
Glistening assessment
Description
Assessment of glistenings by slitlamp determination
Time Frame
2 years postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Domenico Schiano, MD
Organizational Affiliation
Fondazione GB Bietti - IRCCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Azienda Ospedaliera San Giovanni Addolorata - presidio Britannico
City
Rome
ZIP/Postal Code
00184
Country
Italy
Facility Name
Fondazione GB Bietti - IRCCS
City
Rome
ZIP/Postal Code
00198
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Visual Performance Intraocular Lens (IOL) MicroPure 1.2.3.

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