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This study has been withdrawn prior to enrollment.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
  Purpose

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 Intervention Phase
Burn
Dietary Supplement: vitamin c
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effect of Subconjunctival Vitamin c on Recovery Rate and End Result From Eye Burn.

Resource links provided by NLM:


Further study details as provided by The Baruch Padeh Medical Center, Poriya:

Primary Outcome Measures:
  • EXTENSION OF FLORSCEIN PAINT ON THE CORNEA AND CONJUNCTIVA [ Time Frame: BID ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: July 2009
Estimated Study Completion Date: February 2010
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Baruch Pade Medical Center
Dietary Supplement: vitamin c
Subconjunctival daily or bid
Other Names:
  • subconjunctival
  • ascorbic acid
  • vitamin c
Active Comparator: 2
Rambam Medical Center
Dietary Supplement: vitamin c
topical and systemic
Other Names:
  • vitamin c
  • Burn
  • eye
  • ascorbic acid
Active Comparator: 3
Soroka Medical Center
Dietary Supplement: vitamin c
topical systemic
Other Names:
  • vitamin c
  • burn

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.

  Eligibility

Ages Eligible for Study:   up to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:other disease

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734695

Locations
Israel
Movshovitz Ina
Afula, Israel
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
  More Information

No publications provided

Responsible Party: Modi Naftali, Baruch Pade Medical Center
ClinicalTrials.gov Identifier: NCT00734695     History of Changes
Other Study ID Numbers: vitcbrn.CTIL
Study First Received: August 13, 2008
Last Updated: February 28, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by The Baruch Padeh Medical Center, Poriya:
BURN
EYE
VITAMIN C
ASCORBIC ACID

Additional relevant MeSH terms:
Burns
Eye Burns
Wounds and Injuries
Eye Injuries
Facial Injuries
Craniocerebral Trauma
Ascorbic Acid
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 22, 2014