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STROMA-CROSS: Stromal Demarcation Line: is it Predictive for Cross-Linking Efficiency?

Sponsor
Centre Hospitalier Régional Metz-Thionville (Other)
Overall Status
Completed
CT.gov ID
NCT02883868
Collaborator
(none)
36
Enrollment
5
Duration (Months)

Study Details

Study Description

Brief Summary

To assess the association between stromal demarcation line after collagen crosslinking (CXL) for progressive keratoconus and mid-term (6 month) refractive, topographic and clinical outcomes of CXL

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    All consecutive patients treated with CXL between March 2014 and March 2015 were included. They all underwent the same procedure: accelerated-CXL protocol (10 minutes UVA irradiation with 9 mW/cm2 intensity), irradiation device (IROC UV-X™ 2000, Medeuronet). One month after the procedure, AS-OCT examination was performed in all patients (RS-3000, NIDEK). The visibility of the stromal demarcation line was scored (0: not visible line; 1: visible line, but measurement not clearly defined; 2: clearly visible line) and its depth was measured centrally at anytime it was possible. Changes in best corrected visual acuity (BCVA), spherical equivalent (SE), Kmax and thinnest pachymetry, were studied preoperatively and at 6 months

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    36 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Study Start Date :
    Oct 1, 2015
    Actual Primary Completion Date :
    Dec 1, 2015
    Actual Study Completion Date :
    Mar 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    patients treated with CXL

    Outcome Measures

    Primary Outcome Measures

    1. visibility of the stromal demarcation line [month 1]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients treated with CXL
    Exclusion Criteria:

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Centre Hospitalier Régional Metz-Thionville

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Centre Hospitalier Régional Metz-Thionville
    ClinicalTrials.gov Identifier:
    NCT02883868
    Other Study ID Numbers:
    • 2015-09Obs-CHRMT
    First Posted:
    Aug 30, 2016
    Last Update Posted:
    Sep 15, 2016
    Last Verified:
    Aug 1, 2016
    Additional relevant MeSH terms:
    Keratoconus

    Study Results

    No Results Posted as of Sep 15, 2016