NCT01261013

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
219

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Typical duration for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 16, 2010

Completed
Last Updated

December 27, 2010

Status Verified

November 1, 2010

First QC Date

December 14, 2010

Last Update Submit

December 23, 2010

Conditions

Keratoconus

Keywords

Keratoconusintrastromal corneal ring segmentTo evaluate the visual and refractive outcomes of intrastromal corneal ring segment in keratoconic eyes at different stages

Study Arms (3)

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

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 14, 2010

First Posted

December 16, 2010

Study Start

January 1, 2008

Study Completion

March 1, 2010

Last Updated

December 27, 2010

Record last verified: 2010-11