Observation of Rotation of an Intraocular Lens

Cataract Clinical Trial

Official title:

Observation of Rotation of the MC 6125 AS Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02208232
• Other study ID #: EK Nr: 1267/2012
• Status: Completed
• Phase: N/A
• First received: March 27, 2014
• Last updated: August 1, 2014
• Start date: June 2012
• Est. completion date: December 2012

Study information

• Verified date: August 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionAustria: Federal Ministry for Health and Women
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• cataract surgery
cataract surgery with implantation of intraocular lens

Locations

Country	Name	City	State
Austria	Department of Ophthalmology and Optometry of the Medical University Vienna	Vienna	Viena

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IOL rotation	The rotation of the IOLs over the first 6 postoperative months	6 months	No