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

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT02649257

Collaborator

(none)

100

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Procedure: cataract surgery Device: intraocular lens (MC 6125 AS) Device: capsular tension ring (CTR 13/11)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

May 1, 2015

Actual Study Completion Date :

May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MC 6125 AS IOL + CTR 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).	Procedure: cataract surgery Device: intraocular lens (MC 6125 AS) Device: capsular tension ring (CTR 13/11)

Arm

Intervention/Treatment

Experimental: MC 6125 AS IOL + CTR

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).

Procedure: cataract surgery

Device: intraocular lens (MC 6125 AS)

Device: capsular tension ring (CTR 13/11)

Outcome Measures

Primary Outcome Measures

IOL rotation [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Ophthalmology and Optometry of the Medical University Vienna	Vienna	Vianne	Austria	1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rupert Menapace, Ao.Univ.-Prof. Dr.med.univ., Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT02649257

Other Study ID Numbers:

EK-Nr.: 1435/2014

First Posted:

Jan 7, 2016

Last Update Posted:

Jan 12, 2016

Last Verified:

Jan 1, 2016

Keywords provided by Rupert Menapace, Ao.Univ.-Prof. Dr.med.univ., Medical University of Vienna

IOL rotation

capsular tension ring

IOL rotational stability

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Jan 12, 2016