Intrastromal Corneal Ring Segment Implantation in 219 Keratoconic Eyes at Different Stages

This study has been completed.

Sponsor:

Information provided by:

Fernandez-Vega Ophthalmological Institute

ClinicalTrials.gov Identifier:

NCT01261013

First received: December 14, 2010

Last updated: December 23, 2010

Last verified: November 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	December 14, 2010
Last Updated Date	December 23, 2010
Start Date ^ICMJE	January 2008
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01261013 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Intrastromal Corneal Ring Segment Implantation in 219 Keratoconic Eyes at Different Stages
Official Title ^ICMJE	Intrastromal Corneal Ring Segment Implantation in 219 Keratoconic Eyes at Different Stages
Brief Summary	The purpose of this study is to properly analyse the visual and refractive outcomes of implantation of KeraRing intrastromal corneal ring segment (ICRS) at the different stages of keratoconus.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients with keratoconus (stage I; stage II and stage III,according to the Amsler-Krumeich keratoconus classification) in whom KeraRing ICRS were implanted at the Fernández-Vega Ophthalmological Institute, Oviedo, Spain.
Condition ^ICMJE	Keratoconus
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	keratoconus stage I in whom KeraRing ICRS were implanted keratoconus stage II in whom KeraRing ICRS were implanted keratoconus stage III in whom KeraRing ICRS were implanted
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	219
Completion Date	March 2010
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients who had keratoconus Contact lens intolerance and clear cornea. The maximum keratometric reading was less than 60.00 diopters (D) The minimum corneal thickness more than 300 μm. Exclusion Criteria: Acute or grade IV keratoconus. Previous corneal or intraocular surgery. Cataract, history of glaucoma or retinal detachment, macular degeneration or retinopathy, neuro-ophthalmic diseases, and history of ocular inflammation
Gender	Both
Ages	20 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01261013
Other Study ID Numbers ^ICMJE	IOFV-1
Has Data Monitoring Committee	Yes
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Fernandez-Vega Ophthalmological Institute
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Fernandez-Vega Ophthalmological Institute
Verification Date	November 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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