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

Primary Purpose

Burn

Status

Withdrawn

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

vitamin c

About this trial

This is an interventional treatment trial for Burn focused on measuring BURN, EYE, VITAMIN C, ASCORBIC ACID

Eligibility Criteria

undefined - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Eyes clinic patients presented with acute chemical or thermal burn.

Exclusion Criteria:other disease

Sites / Locations

Movshovitz Ina
Naftali Modi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Baruch Pade Medical Center

Rambam Medical Center

Soroka Medical Center

Outcomes

Primary Outcome Measures

EXTENSION OF FLORSCEIN PAINT ON THE CORNEA AND CONJUNCTIVA

Secondary Outcome Measures

Full Information

NCT ID

NCT00734695

First Posted

August 13, 2008

Last Updated

February 28, 2010

Sponsor

The Baruch Padeh Medical Center, Poriya

Collaborators

Rambam Health Care Campus, Soroka University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00734695

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2010

Overall Recruitment Status

Withdrawn

Why Stopped

couldn't recruit patients

Study Start Date

July 2009 (undefined)

Primary Completion Date

November 2009 (Anticipated)

Study Completion Date

February 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

The Baruch Padeh Medical Center, Poriya

Collaborators

Rambam Health Care Campus, Soroka University Medical Center

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Burn

Keywords

BURN, EYE, VITAMIN C, ASCORBIC ACID

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Baruch Pade Medical Center

Arm Title

Arm Type

Active Comparator

Arm Description

Rambam Medical Center

Arm Title

Arm Type

Active Comparator

Arm Description

Soroka Medical Center

Intervention Type

Dietary Supplement

Intervention Name(s)

vitamin c

Other Intervention Name(s)

subconjunctival, ascorbic acid

Intervention Description

Subconjunctival daily or bid

Intervention Type

Dietary Supplement

Intervention Name(s)

vitamin c

Other Intervention Name(s)

Burn, eye, ascorbic acid

Intervention Description

topical and systemic

Intervention Type

Dietary Supplement

Intervention Name(s)

vitamin c

Other Intervention Name(s)

burn

Intervention Description

topical systemic

Primary Outcome Measure Information:

Title

EXTENSION OF FLORSCEIN PAINT ON THE CORNEA AND CONJUNCTIVA

Time Frame

BID

10. Eligibility

Sex

All

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Eyes clinic patients presented with acute chemical or thermal burn. Exclusion Criteria:other disease

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

naftali modi, MD

Organizational Affiliation

Baruch Pade medical center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Movshovitz Ina

City

Afula

Country

Israel

Facility Name

Naftali Modi

City

Tiberia

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

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