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Search / Trial NCT03796624

Clinical Outcomes of MICROPURE and PodEye Monofocal Intraocular Lenses

Launched by BEAVER-VISITEC INTERNATIONAL, INC. · Jan 4, 2019

Trial Information

Current as of May 20, 2025

Completed

Keywords

Intraocular Lens Monofocal Hydrophobic

ClinConnect Summary

This clinical investigation is a prospective, non-randomised, open, controlled, single-center post-market clinical follow whereby study patients undergoing routine cataract surgery will have implantation of monofocal intraocular lens Micropure 1.2.3. (PhysIOL, Liège, Belgium) in one eye and implantation of monofocal intraocular lens PODEYE (PhysIOL, Liège, Belgium) in the contralateral eye of the same patient.

The study purpose is to obtain clinical data on visual acuity and contrast sensitivity on patients implanted with Micropure 1.2.3. and PODEYE

The devices under investigation (Microp...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Cataractous eyes with no comorbidity
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures
  • Clear intraocular media other than cataract;
  • Signed informed consent
  • Exclusion Criteria:
  • Age of patient \< 45 years;
  • Irregular astigmatism;
  • Regular corneal astigmatism \>0.75 dioptres by an automatic keratometer or biometer or \>1.0 dioptres if the steep axis of cylinder is between 90° and 120°;
  • Difficulty for cooperation (distance from their home, general health condition);
  • Previous intraocular or corneal surgery;
  • Traumatic cataract;
  • Any ocular comorbidity;
  • Instability of keratometry or biometry measurements.

About Beaver Visitec International, Inc.

Beaver-Visitec International, Inc. is a leading global medical device company specializing in innovative surgical solutions for ophthalmic and other medical specialties. With a commitment to advancing patient care, the company focuses on developing high-quality, innovative products that enhance surgical precision and improve clinical outcomes. Leveraging extensive research and development expertise, Beaver-Visitec collaborates with healthcare professionals to address unmet needs in the operating room, thereby transforming surgical practices and enhancing patient safety. Through its dedication to excellence and innovation, Beaver-Visitec continues to play a pivotal role in the evolution of surgical technologies.

Locations

Zlin, , Czechia

Patients applied

0 patients applied

Trial Officials

Pavel Stodůlka, MD, PhD

Principal Investigator

Gemini Eye Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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