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Completed

NCT Number: NCT02208232

Observation of Rotation of an 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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Ophthalmology and Optometry of the Medical University Vienna

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

cataract surgery

Procedure

cataract surgery with implantation of intraocular lens

Primary outcomes

  1. IOL rotation

    Time frame: 6 months

    The rotation of the IOLs over the first 6 postoperative months

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

Observation of Rotation of the MC 6125 AS Intraocular Lens

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 5, 2014
Registry last updated
Aug 5, 2014

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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