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

NCT ID: NCT00734695

Last Updated: 2010-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-02-28

Brief Summary

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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

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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.

Conditions

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Burn

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Baruch Pade Medical Center

Group Type EXPERIMENTAL

vitamin c

Intervention Type DIETARY_SUPPLEMENT

Subconjunctival daily or bid

2

Rambam Medical Center

Group Type ACTIVE_COMPARATOR

vitamin c

Intervention Type DIETARY_SUPPLEMENT

topical and systemic

3

Soroka Medical Center

Group Type ACTIVE_COMPARATOR

vitamin c

Intervention Type DIETARY_SUPPLEMENT

topical systemic

Interventions

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vitamin c

Subconjunctival daily or bid

Intervention Type DIETARY_SUPPLEMENT

vitamin c

topical and systemic

Intervention Type DIETARY_SUPPLEMENT

vitamin c

topical systemic

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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subconjunctival ascorbic acid Burn eye ascorbic acid burn

Eligibility Criteria

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Inclusion Criteria

* Eyes clinic patients presented with acute chemical or thermal burn.
Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rambam Health Care Campus

OTHER

Sponsor Role collaborator

Soroka University Medical Center

OTHER

Sponsor Role collaborator

The Baruch Padeh Medical Center, Poriya

OTHER_GOV

Sponsor Role lead

Responsible Party

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Baruch Pade Medical Center

Principal Investigators

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naftali modi, MD

Role: PRINCIPAL_INVESTIGATOR

Baruch Pade medical center

Locations

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Movshovitz Ina

Afula, , Israel

Site Status

Naftali Modi

Tiberias, , Israel

Site Status

Countries

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Israel

Other Identifiers

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vitcbrn.CTIL

Identifier Type: -

Identifier Source: org_study_id

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