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

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ClinicalTrials.gov Identifier: NCT01261013
Recruitment Status : Completed
First Posted : December 16, 2010
Last Update Posted : December 27, 2010
Sponsor:
Information provided by:
Fernandez-Vega Ophthalmological Institute

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.

Condition or disease
Keratoconus

Study Type : Observational
Actual Enrollment : 219 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Intrastromal Corneal Ring Segment Implantation in 219 Keratoconic Eyes at Different Stages
Study Start Date : January 2008
Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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




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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

ClinicalTrials.gov Identifier: NCT01261013     History of Changes
Other Study ID Numbers: IOFV-1
First Posted: December 16, 2010    Key Record Dates
Last Update Posted: December 27, 2010
Last Verified: November 2010

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