Observation of Rotation of an Intraocular Lens

Completed

• Conditions: Cataract

• 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

Study Timeline

• Study Start: 2012-06
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2014-03-27
• Status Verified: 2014-08
• Study First Submitted QC: 2014-08-01
• Last Update Submitted: 2014-08-01
• Study First Posted: 2014-08-05
• Last Update Posted: 2014-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IOL rotation	6 months	The rotation of the IOLs over the first 6 postoperative months

Trial Locations

Locations (1)

Department of Ophthalmology and Optometry of the Medical University Vienna; 🇦🇹 Vienna, Viena, Austria