Visual Performance Intraocular Lens (IOL) MicroPure 1.2.3.

Not Applicable

Completed

• Conditions: Cataract; Lens Opacities
• Interventions: Device: IOL implantation

• Registration Number: NCT03297372
• Lead Sponsor: Beaver-Visitec International, Inc.

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.

Study Timeline

• Study First Submitted: 2017-09-26
• Study First Submitted QC: 2017-09-28
• Study First Posted: 2017-09-29
• Study Start: 2017-10-23
• Primary Completion: 2022-09-08
• Study Completion: 2022-09-08
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-27
• Last Update Posted: 2022-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IOL Implantation experimental	IOL implantation	Implantation of Micropure 1.2.3. in one of the eyes of the study subject

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (2)

Azienda Ospedaliera San Giovanni Addolorata - presidio Britannico; 🇮🇹 Rome, Italy

Fondazione GB Bietti - IRCCS; 🇮🇹 Rome, Italy