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

This study has been withdrawn prior to enrollment.
(couldn't recruit patients)
Sponsor:
Collaborators:
Rambam Health Care Campus
Soroka University Medical Center
Information provided by:
The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov Identifier:
NCT00734695
First received: August 13, 2008
Last updated: February 28, 2010
Last verified: February 2010

August 13, 2008
February 28, 2010
July 2009
November 2009   (final data collection date for primary outcome measure)
EXTENSION OF FLORSCEIN PAINT ON THE CORNEA AND CONJUNCTIVA [ Time Frame: BID ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00734695 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparing the Use of Vitamin c (Ascorbic Acid) in Eye Burn in Subconjunctival Injection to Topical or Oral Treatment.
The Effect of Subconjunctival Vitamin c on Recovery Rate and End Result From Eye Burn.

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Burn
  • Dietary Supplement: vitamin c
    Subconjunctival daily or bid
    Other Names:
    • subconjunctival
    • ascorbic acid
    • vitamin c
  • Dietary Supplement: vitamin c
    topical and systemic
    Other Names:
    • vitamin c
    • Burn
    • eye
    • ascorbic acid
  • Dietary Supplement: vitamin c
    topical systemic
    Other Names:
    • vitamin c
    • burn
  • Experimental: 1
    Baruch Pade Medical Center
    Intervention: Dietary Supplement: vitamin c
  • Active Comparator: 2
    Rambam Medical Center
    Intervention: Dietary Supplement: vitamin c
  • Active Comparator: 3
    Soroka Medical Center
    Intervention: Dietary Supplement: vitamin c
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
20
February 2010
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Eyes clinic patients presented with acute chemical or thermal burn.

Exclusion Criteria:other disease

Both
up to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00734695
vitcbrn.CTIL
No
Modi Naftali, Baruch Pade Medical Center
The Baruch Padeh Medical Center, Poriya
  • Rambam Health Care Campus
  • Soroka University Medical Center
Principal Investigator: naftali modi, MD Baruch Pade medical center
The Baruch Padeh Medical Center, Poriya
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP