Visual Performance Intraocular Lens (IOL) MicroPure 1.2.3.

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03297372
• Other study ID #: PHY1604
• Status: Completed
• Phase: N/A
• Start date: October 23, 2017
• Est. completion date: September 8, 2022

Study information

• Verified date: October 2022
• Source: Beaver-Visitec International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: September 8, 2022
• Est. primary completion date: September 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Lens Opacities

Intervention

Device:
• IOL implantation
Implantation of monofocal IOL Micropure 1.2.3

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera San Giovanni Addolorata - presidio Britannico	Rome
Italy	Fondazione GB Bietti - IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Beaver-Visitec International, Inc.

Country where clinical trial is conducted

Italy, 

Outcome

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