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Comparing the Use of Vitamin c (Ascorbic Acid) in Eye Burn in Subconjunctival Injection to Topical or Oral Treatment.

Sponsor
The Baruch Padeh Medical Center, Poriya (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00734695
Collaborator
Rambam Health Care Campus (Other), Soroka University Medical Center (Other)
20
Enrollment
2
Locations
3
Arms
7.1
Duration (Months)
10
Patients Per Site
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Eye burns may cause a severe permanent damage. One kind of treatment is the use of vitamin C (Ascorbic acid). This study will compare between subconjunctival topical and/or systemic route of administration and topical and/or systemic administration.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: vitamin c
  • Dietary Supplement: vitamin c
  • Dietary Supplement: vitamin c
 Phase 1

Detailed Description

In order to prevent permanent and severe damage to the eye after eye burn early treatment is mandatory. It is well known and published that the use of Vitamin c may contribute to the healing process of such burns, including burns from chemicals or heat. We believe that the route pf administration of the medicine is as important as the kind of medicine and that subconjunctival injection will have better effect and will influence in a favorable manner on the the end result as well as on the time of the healing.

In order to be able to compare between cases we made a new definition of the severity of the burn according to the extension of the damage on the cornea, conjunctiva and limbus, and according to the severity and depth of the ischemia.

In 3 medical centers 3 protocols of treatment and followup will be compared while only in Baruch Pade Medical Center the main route of administration will be subconjunctival on top of the topical treatment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effect of Subconjunctival Vitamin c on Recovery Rate and End Result From Eye Burn.
Study Start Date :
Jul 1, 2009
Anticipated Primary Completion Date :
Nov 1, 2009
Anticipated Study Completion Date :
Feb 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Baruch Pade Medical Center

Dietary Supplement: vitamin c
Subconjunctival daily or bid
Other Names:
  • subconjunctival
  • ascorbic acid

    		•
    Active Comparator: 2

    Rambam Medical Center

    Dietary Supplement: vitamin c
    topical and systemic
    Other Names:
  • Burn
  • eye
  • ascorbic acid

    		•
    Active Comparator: 3

    Soroka Medical Center

    Dietary Supplement: vitamin c
    topical systemic
    Other Names:
  • burn

    		•

    Outcome Measures

    Primary Outcome Measures

    1. EXTENSION OF FLORSCEIN PAINT ON THE CORNEA AND CONJUNCTIVA [BID]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Eyes clinic patients presented with acute chemical or thermal burn.

    Exclusion Criteria:other disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Movshovitz Ina Afula Israel
    2 Naftali Modi Tiberia Israel

    Sponsors and Collaborators

    • The Baruch Padeh Medical Center, Poriya
    • Rambam Health Care Campus
    • Soroka University Medical Center

    Investigators

    • Principal Investigator: naftali modi, MD, Baruch Pade medical center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00734695
    Other Study ID Numbers:
    • vitcbrn.CTIL
    First Posted:
    Aug 14, 2008
    Last Update Posted:
    Mar 2, 2010
    Last Verified:
    Feb 1, 2010
    Keywords provided by , ,
    BURN
    EYE
    VITAMIN C
    ASCORBIC ACID
    Additional relevant MeSH terms:
    Eye Burns
    Burns
    Vitamins
    Ascorbic Acid

    Study Results

    No Results Posted as of Mar 2, 2010