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

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology and Optometry of the Medical University Vienna

Vienna, Vianne, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cataract surgery

Procedure

intraocular lens (MC 6125 AS)

Device

capsular tension ring (CTR 13/11)

Device

Primary outcomes

IOL rotation

Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Jan 7, 2016
Registry last updated: Jan 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed