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

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Procedure: cataract surgery; Device: intraocular lens (MC 6125 AS); Device: capsular tension ring (CTR 13/11)

• Registration Number: NCT02649257
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Study First Submitted: 2015-12-22
• Status Verified: 2016-01
• Study First Submitted QC: 2016-01-06
• Study First Posted: 2016-01-07
• Last Update Submitted: 2016-01-11
• Last Update Posted: 2016-01-12

Recruitment & Eligibility

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

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MC 6125 AS IOL + CTR	intraocular lens (MC 6125 AS)	All patients received the same procedure: cataract surgery with phakoemulsification, implantation of a capsular tension ring (CTR13/11) and implantation of an intraocular lens (MC 6125 AS).
MC 6125 AS IOL + CTR	cataract surgery	All patients received the same procedure: cataract surgery with phakoemulsification, implantation of a capsular tension ring (CTR13/11) and implantation of an intraocular lens (MC 6125 AS).
MC 6125 AS IOL + CTR	capsular tension ring (CTR 13/11)	All patients received the same procedure: cataract surgery with phakoemulsification, implantation of a capsular tension ring (CTR13/11) and implantation of an intraocular lens (MC 6125 AS).

Primary Outcome Measures

Name	Time	Method
IOL rotation	6 months

Trial Locations

Locations (1)

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