NCT02649257

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

10 months

First QC Date

December 22, 2015

Last Update Submit

January 11, 2016

Conditions

Cataract

Keywords

IOL rotationcapsular tension ringIOL rotational stability

Outcome Measures

Primary Outcomes (1)

  • IOL rotation

    6 months

Study Arms (1)

MC 6125 AS IOL + CTR

EXPERIMENTAL

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 surgeryDevice: intraocular lens (MC 6125 AS)Device: capsular tension ring (CTR 13/11)

Interventions

cataract surgeryPROCEDURE
MC 6125 AS IOL + CTR
intraocular lens (MC 6125 AS)DEVICE
MC 6125 AS IOL + CTR
capsular tension ring (CTR 13/11)DEVICE
MC 6125 AS IOL + CTR

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology and Optometry of the Medical University Vienna

Vienna, Vianne, 1090, Austria

Location

MeSH Terms

Conditions

Cataract

Interventions

Cataract ExtractionLenses, Intraocular

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical ProceduresOphthalmologic Surgical ProceduresSurgical Procedures, OperativeLensesOptical DevicesEquipment and SuppliesProstheses and Implants

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ao.Univ.-Prof. Dr.med.univ.

Study Record Dates

First Submitted

December 22, 2015

First Posted

January 7, 2016

Study Start

July 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations

AU(1)