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Observation of Rotation of an Intraocular Lens

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT02208232
Collaborator
(none)
100
Enrollment
1
Location
6
Duration (Months)
16.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: cataract surgery

Study Design

Study Type:
Observational
Actual Enrollment :
100 participants
Official Title:
Observation of Rotation of the MC 6125 AS Intraocular Lens
Study Start Date :
Jun 1, 2012
Actual Primary Completion Date :
Dec 1, 2012
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. IOL rotation [6 months]

    The rotation of the IOLs over the first 6 postoperative months

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Ophthalmology and Optometry of the Medical University Vienna Vienna Viena Austria 1090

Sponsors and Collaborators

  • Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rupert Menapace, Ao.Univ.-Prof. Dr.med.univ., Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT02208232
Other Study ID Numbers:
  • EK Nr: 1267/2012
First Posted:
Aug 5, 2014
Last Update Posted:
Aug 5, 2014
Last Verified:
Aug 1, 2014
Keywords provided by Rupert Menapace, Ao.Univ.-Prof. Dr.med.univ., Medical University of Vienna
IOL rotation
Additional relevant MeSH terms:
Cataract

Study Results

No Results Posted as of Aug 5, 2014