Visual Performance Intraocular Lens (IOL) MicroPure 1.2.3.

Clinical Study to Investigate Visual Performance of Hydrophobic Monofocal IOL: MicroPure 1.2.3.

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).

Study Overview

• Status: Completed
• Conditions: Cataract; Lens Opacities
• Intervention / Treatment: Device: IOL implantation

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 Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00184
    • Azienda Ospedaliera San Giovanni Addolorata - presidio Britannico
  • Rome, Italy, 00198
    • Fondazione GB Bietti - IRCCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 41 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Posterior capsule opacification (PCO) grading	grade of the PCO determined by slitlamp	2 years postoperative
Uncorrected Distance Visual acuity (UDVA)	Monocular Uncorrected Distance Visual acuity (UDVA)	6 months postoperative
Contrast Sensitivity	Contrast Sensitivity under photopic and mesopic light conditions	6 months postoperative
Glistening assessment	Assessment of glistenings by slitlamp determination	2 years postoperative

Collaborators and Investigators

• Sponsor: Beaver-Visitec International, Inc.
• Investigators: Principal Investigator: Domenico Schiano, MD, Fondazione GB Bietti - IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2017
• Primary Completion (Actual): September 8, 2022
• Study Completion (Actual): September 8, 2022

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: September 28, 2017
• First Posted (Actual): September 29, 2017

Study Record Updates

• Last Update Posted (Actual): October 28, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: cataract; Intraocular lens; monofocal; PhysIOL
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: PHY1604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No