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Corneal Thickness Changes During Corneal Collagen Cross-linking With Ultraviolet-A Irradiation and Riboflavin

Sponsor
Instituto de Olhos de Goiania (Other)
Overall Status
Completed
CT.gov ID
NCT01485211
Collaborator
(none)
18
Enrollment
1
Arm
22
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the corneal pachymetric variations during and after corneal collagen cross-linking (CXL) treatment with ultraviolet-A irradiation (UVA) and hypo-osmolar riboflavin solution in thin corneas.

Condition or Disease Intervention/Treatment Phase
  • Drug: cross-linking with hypo-osmolar riboflavin
 Phase 4

Detailed Description

To evaluate the corneal pachymetric variations during and after corneal collagen cross-linking (CXL) treatment with ultraviolet-A irradiation (UVA) and hypo-osmolar riboflavin solution in thin corneas.

Eighteen eyes of 18 patients, 11 men and 7 women, with progressive keratoconus and thinnest corneal thickness (TCT) less than 400µm were included in this study.

After the epithelium removal, iso-osmolar riboflavin was applied to the cornea every 3 minutes (30 min). Hipo-osmolar riboflavin was then applied every 20 seconds until the TCT reached 400µm. UVA irradiation was performed for 30 min. Pachymetry was recorded at the thinnest point of the cornea preoperatively, after epithelial removal, after iso-osmolar riboflavin, after hypo-osmolar riboflavin, after UVA irradiation, and at 1, 6 and 12 months.

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Corneal Thickness Changes During Corneal Collagen Cross-linking With Ultraviolet-A Irradiation and Hypo-osmolar Riboflavin Solution in Thin Corneas
Study Start Date :
Jan 1, 2010
Actual Primary Completion Date :
Nov 1, 2011
Actual Study Completion Date :
Nov 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: crosslinking with hypoosmolar riboflavin

Riboflavin and UVA-induced corneal cross-linking increases the stability of keratoconic corneas. The current inclusion criteria require a minimum stromal thickness of 400 µm. Hypo-osmolar riboflavin solution increases the stromal thickness before CXL in cases with preoperatively thin corneas.

Drug: cross-linking with hypo-osmolar riboflavin
Hipo-osmolar riboflavin was applied every 20 seconds until the TCT reached 400µm. UVA irradiation was performed for 30 min. Pachymetry was recorded at the thinnest point of the cornea preoperatively, after epithelial removal, after iso-osmolar riboflavin, after hypo-osmolar riboflavin, after UVA irradiation, and at 1, 6 and 12 months.
Other Names:
  • Riboflavin
  • UVA radiation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Corneal thickness changes during corneal collagen cross-linking with ultraviolet-A irradiation and hypo-osmolar riboflavin solution in thin corneas [Pachymetry was recorded at the thinnest point of the cornea preoperatively, after epithelial removal, after iso-osmolar riboflavin, after hypo-osmolar riboflavin, after UVA irradiation, and at 1, 6 and 12 months.]

      To evaluate the corneal pachymetric variations during and after corneal collagen cross-linking treatment with ultraviolet-A irradiation and hypo-osmolar riboflavin solution in thin corneas with progressive keratoconus.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Progressive Keratoconus

    • thin corneas

    Exclusion Criteria:

    • Contact lens use for less than 3 weeks

    • Non progressive keratoconus

    • Thinest corneal thickness above 400 micra

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Instituto de Olhos de Goiania

    Investigators

    • Study Chair: Belquiz A Nassaralla, MD, PhD, Instituto de Olhos de Goiania

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Joao Nassaralla, Clinical Professor, Instituto de Olhos de Goiania
    ClinicalTrials.gov Identifier:
    NCT01485211
    Other Study ID Numbers:
    • BQ - 5 - 11 -ARVO
    First Posted:
    Dec 5, 2011
    Last Update Posted:
    Dec 5, 2011
    Last Verified:
    Nov 1, 2011
    Keywords provided by Joao Nassaralla, Clinical Professor, Instituto de Olhos de Goiania
    progressive keratoconus
    thin corneas
    cross-linking
    hypo-osmolar riboflavin
    Additional relevant MeSH terms:
    Keratoconus
    Corneal Diseases
    Riboflavin

    Study Results

    No Results Posted as of Dec 5, 2011