NCT02208232

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 5, 2014

Completed
Last Updated

August 5, 2014

Status Verified

August 1, 2014

Enrollment Period

6 months

First QC Date

March 27, 2014

Last Update Submit

August 1, 2014

Conditions

Cataract

Keywords

IOL rotation

Outcome Measures

Primary Outcomes (1)

  • IOL rotation

    The rotation of the IOLs over the first 6 postoperative months

    6 months

Study Arms (1)

MC 6125 AS IOL

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

Procedure: cataract surgery

Interventions

cataract surgeryPROCEDURE

cataract surgery with implantation of intraocular lens

MC 6125 AS IOL

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology and Optometry of the Medical University Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ao.Univ.-Prof. Dr.med.univ.

Study Record Dates

First Submitted

March 27, 2014

First Posted

August 5, 2014

Study Start

June 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

August 5, 2014

Record last verified: 2014-08

Locations

AU(1)