Visual Performance Intraocular Lens (IOL) MicroPure 1.2.3.

NCT ID: NCT03297372

Last Updated: 2022-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-23
• Study Completion Date: 2022-09-08

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.

Conditions

Cataract; Lens Opacities

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IOL Implantation experimental

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

Group Type: EXPERIMENTAL

IOL implantation

Intervention Type: DEVICE

Implantation of monofocal IOL Micropure 1.2.3

Interventions

IOL implantation

Implantation of monofocal IOL Micropure 1.2.3

Intervention Type: DEVICE

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beaver-Visitec International, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Domenico Schiano, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione GB Bietti - IRCCS

Locations

Azienda Ospedaliera San Giovanni Addolorata - presidio Britannico

Rome, , Italy

Fondazione GB Bietti - IRCCS

Rome, , Italy

Countries

Italy

Other Identifiers

PHY1604

Identifier Type: -

Identifier Source: org_study_id