Intrastromal Corneal Ring Segment Implantation in 219 Ker... | NCT01261013

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

NCT01261013

Sponsor

Fernandez-Vega Ophthalmological Institute

Status

Completed

Last Update Posted

Dec 27, 2010Estimated

Enrollment

219Actual

Phase

Not provided

Conditions

Keratoconus

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Not provided

Completion Date

Mar 2010

First Submitted Date

Dec 14, 2010

First Submission Date that Met QC Criteria

Dec 15, 2010

First Posted Date

Dec 16, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2010

Last Update Posted Date

Dec 27, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

219Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

ID	Term
D003316	Corneal Diseases
D005128	Eye Diseases