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

February 28, 2010 updated by: The Baruch Padeh Medical Center, Poriya

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel
        • Movshovitz Ina
      • Tiberia, Israel
        • Naftali Modi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 90 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:other disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Baruch Pade Medical Center
Dietary supplement: vitamin c
Subconjunctival daily or bid
Other Names:
  • ascorbic acid
  • subconjunctival
Dietary supplement: vitamin c
topical and systemic
Other Names:
  • ascorbic acid
  • Burn
  • eye
Dietary supplement: vitamin c
topical systemic
Other Names:
  • burn
ACTIVE_COMPARATOR: 2
Rambam Medical Center
Dietary supplement: vitamin c
Subconjunctival daily or bid
Other Names:
  • ascorbic acid
  • subconjunctival
Dietary supplement: vitamin c
topical and systemic
Other Names:
  • ascorbic acid
  • Burn
  • eye
Dietary supplement: vitamin c
topical systemic
Other Names:
  • burn
ACTIVE_COMPARATOR: 3
Soroka Medical Center
Dietary supplement: vitamin c
Subconjunctival daily or bid
Other Names:
  • ascorbic acid
  • subconjunctival
Dietary supplement: vitamin c
topical and systemic
Other Names:
  • ascorbic acid
  • Burn
  • eye
Dietary supplement: vitamin c
topical systemic
Other Names:
  • burn

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
EXTENSION OF FLORSCEIN PAINT ON THE CORNEA AND CONJUNCTIVA
Time Frame: BID
BID

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Baruch Padeh Medical Center, Poriya

Collaborators

Rambam Health Care Campus
Soroka University Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ANTICIPATED)

November 1, 2009

Study Completion (ANTICIPATED)

February 1, 2010

Study Registration Dates

First Submitted

August 13, 2008

First Submitted That Met QC Criteria

August 13, 2008

First Posted (ESTIMATE)

August 14, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 2, 2010

Last Update Submitted That Met QC Criteria

February 28, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • vitcbrn.CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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