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

Sponsor
Fernandez-Vega Ophthalmological Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01261013
Collaborator
(none)
219
Enrollment
26
Duration (Months)

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Jan 1, 2008
    Study Completion Date :
    Mar 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      20 Years to 60 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Fernandez-Vega Ophthalmological Institute

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01261013
      Other Study ID Numbers:
      • IOFV-1
      First Posted:
      Dec 16, 2010
      Last Update Posted:
      Dec 27, 2010
      Last Verified:
      Nov 1, 2010
      Keywords provided by , ,
      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

      Study Results

      No Results Posted as of Dec 27, 2010