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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
  Purpose

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.


Condition Phase
Keratoconus
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Intrastromal Corneal Ring Segment Implantation in 219 Keratoconic Eyes at Different Stages

Further study details as provided by Fernandez-Vega Ophthalmological Institute:

Enrollment: 219
Study Start Date: January 2008
Estimated Study Completion Date: March 2010
Groups/Cohorts
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

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01261013     History of Changes
Other Study ID Numbers: IOFV-1
Study First Received: December 14, 2010
Last Updated: December 23, 2010
Health Authority: Spain: Comité Ético del Instituto Oftalmológico Fernández-Vega

Keywords provided by Fernandez-Vega Ophthalmological Institute:
Keratoconus
intrastromal corneal ring segment
To evaluate the visual and refractive outcomes of intrastromal corneal ring segment in keratoconic eyes at different stages

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on June 17, 2013