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Safety and Efficacy of a Novel Hydrophobic Acrylic IOL - iPure: a Randomised Study

NCT04329754 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2022-10-17

No results posted yet for this study

Summary

In this study the rotational stability and performance - with respect to glistening and PCO formation - of a new hydrophobic acrylic IOL (IPure, PhysIOL, Belgium) will be compared to a gold standard IOL (AMO ZCB00) in a randomized controlled fashion. Fifty eyes of 50 patients will be included. 25 patients will receive the iPure and 25 patients will receive the standard IOL. Study hypothesis: The iPure IOL shows better rotational stability compared to the standard IOL. A clinically relevant difference for rotational stability is defined as 2°.

Conditions

  • Cataract

Interventions

DEVICE

Cataract surgery

Cataract surgery with implantation of an intraocular lens (IOL)

Sponsors & Collaborators

  • Vienna Institute for Research in Ocular Surgery

    lead OTHER

Principal Investigators

  • Oliver Findl, MD, MBA · VIROS, Hanusch Hospital Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04329754 on ClinicalTrials.gov