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

Medical University of Vienna

Status: Completed

Conditions: Cataract

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02649257

EK-Nr.: 1435/2014

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No 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

Trial design

100 participants in 1 patient group

MC 6125 AS IOL + CTR

Experimental group

Description:

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).

Treatment:

Procedure: cataract surgery

Device: intraocular lens (MC 6125 AS)

Device: capsular tension ring (CTR 13/11)