Influence of an Capsular Tension Ring on the Rotation of an Intraocular Lens (Aspira®-aA Also Known as MC 6125 AS)

Cataract Clinical Trial

Official title:

Influence of an Capsular Tension Ring on the Rotation of an Intraocular Lens (Aspira®-aA Also Known as MC 6125 AS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02649257
• Other study ID #: EK-Nr.: 1435/2014
• Status: Completed
• Phase: N/A
• First received: December 22, 2015
• Last updated: January 11, 2016
• Start date: July 2014
• Est. completion date: May 2015

Study information

• Verified date: January 2016
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to observe the axial IOL rotation after surgery with a capsular tension ring (CTR) and a MC6125 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: May 2015
• Est. primary completion date: May 2015
• 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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• cataract surgery

Device:
• intraocular lens (MC 6125 AS)

• capsular tension ring (CTR 13/11)

Locations

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

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		6 months	No