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OpenTrials
Completed

NCT Number: NCT03297372

Visual Performance Intraocular Lens (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).

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Key information

Conditions

Cataract Eye Diseases Lens Diseases Lens Opacities

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda Ospedaliera San Giovanni Addolorata - presidio Britannico, Rome, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IOL Implantation

Device

Implantation of monofocal IOL Micropure 1.2.3

Primary outcomes

  1. monocular Corrected Distance Visual Acuity (CDVA) under photopic conditions

    Time frame: 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 outcomes

  1. Posterior capsule opacification (PCO) grading

    Time frame: 2 years postoperative

    grade of the PCO determined by slitlamp

  2. Uncorrected Distance Visual acuity (UDVA)

    Time frame: 6 months postoperative

    Monocular Uncorrected Distance Visual acuity (UDVA)

  3. Contrast Sensitivity

    Time frame: 6 months postoperative

    Contrast Sensitivity under photopic and mesopic light conditions

  4. Glistening assessment

    Time frame: 2 years postoperative

    Assessment of glistenings by slitlamp determination

Sponsors and collaborators

Lead sponsor

Beaver-Visitec International, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Sep 29, 2017
Registry last updated
Oct 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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