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Observation of Rotation of an Intraocular Lens

Completed
Conditions
Cataract
Interventions
Procedure: cataract surgery
Registration Number
NCT02208232
Lead Sponsor
Medical University of Vienna
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
100
Inclusion Criteria
  • Uni or bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation
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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
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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
MC 6125 AS IOLcataract surgerycataract surgery with implantation of intraocular lens MC 6125 AS in one eye
Primary Outcome Measures
NameTimeMethod
IOL rotation6 months

The rotation of the IOLs over the first 6 postoperative months

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Department of Ophthalmology and Optometry of the Medical University Vienna

🇦🇹

Vienna, Viena, Austria

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