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Observation of Rotation of an Intraocular Lens

Primary Purpose

Cataract

Status
Completed
Phase
Locations
Austria
Study Type
Observational
Intervention
cataract surgery
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Cataract focused on measuring IOL rotation

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Ophthalmology and Optometry of the Medical University Vienna

Arms of the Study

Arm 1

Arm Type

Arm Label

MC 6125 AS IOL

Arm Description

cataract surgery with implantation of intraocular lens MC 6125 AS in one eye

Outcomes

Primary Outcome Measures

IOL rotation
The rotation of the IOLs over the first 6 postoperative months

Secondary Outcome Measures

Full Information

First Posted
March 27, 2014
Last Updated
August 1, 2014
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT02208232
Brief Title
Observation of Rotation of an Intraocular Lens
Official Title
Observation of Rotation of the MC 6125 AS Intraocular Lens
Study Type
Observational

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
IOL rotation

7. Study Design

Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MC 6125 AS IOL
Arm Description
cataract surgery with implantation of intraocular lens MC 6125 AS in one eye
Intervention Type
Procedure
Intervention Name(s)
cataract surgery
Intervention Description
cataract surgery with implantation of intraocular lens
Primary Outcome Measure Information:
Title
IOL rotation
Description
The rotation of the IOLs over the first 6 postoperative months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 Population Description
Eyes of patients with uni- or bilateral cataract applying for cataract surgery at the Department of Ophthalmology, Medical University Vienna.
Sampling Method
Non-Probability Sample
Facility Information:
Facility Name
Department of Ophthalmology and Optometry of the Medical University Vienna
City
Vienna
State/Province
Viena
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

Observation of Rotation of an Intraocular Lens

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