Visual Performance Intraocular Lens (IOL) MicroPure 1.2.3.

NCT03297372 | Completed

• 1 other identifier: PHY1604
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 2

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).

Conditions

Cataract; Lens Opacities

Keywords

Intraocular lens; monofocal; cataract; PhysIOL

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Posterior capsule opacification (PCO) grading

  2 years postoperative

• Uncorrected Distance Visual acuity (UDVA)

  6 months postoperative

• Contrast Sensitivity

  6 months postoperative

• Glistening assessment

  2 years postoperative

Study Arms (1)

IOL Implantation experimental

EXPERIMENTAL

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

Device: IOL implantation

Interventions

IOL implantation DEVICE

Implantation of monofocal IOL Micropure 1.2.3

IOL Implantation experimental

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beaver-Visitec International, Inc.: lead

Study Sites (2)

Azienda Ospedaliera San Giovanni Addolorata - presidio Britannico

Rome, 00184, Italy

Location

Fondazione GB Bietti - IRCCS

Rome, 00198, Italy

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Domenico Schiano, MD

  Fondazione GB Bietti - IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: September 29, 2017
• Study Start: October 23, 2017
• Primary Completion: September 8, 2022
• Study Completion: September 8, 2022
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)