Observation of Rotation of an Intraocular Lens

August 1, 2014 updated by: Rupert Menapace, Medical University of Vienna

Observation of Rotation of the MC 6125 AS Intraocular Lens

The purpose of this study is to assess the axial IOL rotation after surgery with an MC 6125 AS IOL.

At the end of surgery the orientation of the IOL is documented with a short video clip via the operating microscope unit. Follow-up examinations are performed 1 hour, 1 week and 6 months after surgery. Rotational stability of the IOL is assessed using retroillumination images with a method to avoid bias from cyclorotation or head tilt.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Viena
      • Vienna, Viena, Austria, 1090
        • Department of Ophthalmology and Optometry of the Medical University Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Eyes of patients with uni- or bilateral cataract applying for cataract surgery at the Department of Ophthalmology, Medical University Vienna.

Description

Inclusion Criteria:

  • Uni or bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation

Exclusion Criteria:

  • Preceding ocular surgery or trauma
  • Recurrent intraocular inflammation of unknown etiology
  • Uncontrolled glaucoma
  • Uncontrolled systemic or ocular disease
  • Blind fellow eye
  • Microphthalmus
  • Corneal abnormality
  • History of uveitis/iritis
  • Iris neovascularization
  • Pseudoexfoliation
  • Proliferative diabetic retinopathy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MC 6125 AS IOL
cataract surgery with implantation of intraocular lens MC 6125 AS in one eye
Procedure: cataract surgery
cataract surgery with implantation of intraocular lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOL rotation
Time Frame: 6 months
The rotation of the IOLs over the first 6 postoperative months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 27, 2014

First Submitted That Met QC Criteria

August 1, 2014

First Posted (Estimate)

August 5, 2014

Study Record Updates

Last Update Posted (Estimate)

August 5, 2014

Last Update Submitted That Met QC Criteria

August 1, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK Nr: 1267/2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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