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

Burn Clinical Trial

Official title:

The Effect of Subconjunctival Vitamin c on Recovery Rate and End Result From Eye Burn.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00734695
• Other study ID #: vitcbrn.CTIL
• Status: Withdrawn
• Phase: Phase 1
• First received: August 13, 2008
• Last updated: February 28, 2010
• Start date: July 2009
• Est. completion date: February 2010

Study information

• Verified date: February 2010
• Source: The Baruch Padeh Medical Center, Poriya
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 20
• Est. completion date: February 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 90 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:other disease

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burn
• Burns

Intervention

Dietary Supplement:
• vitamin c
Subconjunctival daily or bid
• vitamin c
topical and systemic
• vitamin c
topical systemic

Locations

Country	Name	City	State
Israel	Movshovitz Ina	Afula
Israel	Naftali Modi	Tiberia

Sponsors (3)

Lead Sponsor	Collaborator
The Baruch Padeh Medical Center, Poriya	Rambam Health Care Campus, Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EXTENSION OF FLORSCEIN PAINT ON THE CORNEA AND CONJUNCTIVA		BID	No