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Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients

Primary Purpose

Corneal Ulcer

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lidocaine/NSS
NSS/Lidocaine
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corneal Ulcer focused on measuring corneal ulcer, painless, subconjunctival injection, antibiotics, antifungal, lidocaine

Eligibility Criteria

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

Inclusion Criteria:

  • The corneal ulcer patients who are diagnosed by ophthalmologist and have 2 of 3 in these following features.

    1. corneal epithelial defect with stromal infiltration
    2. reaction in anterior chamber
    3. positive for bacteria or fungus
  • The patients have to receive subconjunctival antibiotic injection twice at least.
  • The patients must be informed consent.

Exclusion Criteria:

  • The patients who have history of allergy of local anesthetics, antibiotics or antifungal drugs.
  • The patients who administered NSAIDs or weak opioids within 24 hours prior to subconjunctival antibiotic/antifungal injection.
  • Unable to cooperate with the treatment.
  • Pregnant women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    NSS/Lidocaine

    Lidocaine/NSS

    Arm Description

    First injection: Normal saline Second injection: 2% Lidocaine without adrenaline

    First injection: 2% Lidocaine without adrenaline Second injection: Normal saline

    Outcomes

    Primary Outcome Measures

    Numeric rating scale

    Secondary Outcome Measures

    Side effects

    Full Information

    First Posted
    November 11, 2008
    Last Updated
    March 10, 2019
    Sponsor
    Mahidol University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00789646
    Brief Title
    Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients
    Official Title
    Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Terminated
    Why Stopped
    Very slow in enrolling participants
    Study Start Date
    June 2008 (undefined)
    Primary Completion Date
    December 2008 (Actual)
    Study Completion Date
    June 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Mahidol University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The propose of this study is to determine the efficacy of 2% xylocaine in reducing pain due to subconjunctival antibiotic and antifungal injection.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Corneal Ulcer
    Keywords
    corneal ulcer, painless, subconjunctival injection, antibiotics, antifungal, lidocaine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    NSS/Lidocaine
    Arm Type
    Experimental
    Arm Description
    First injection: Normal saline Second injection: 2% Lidocaine without adrenaline
    Arm Title
    Lidocaine/NSS
    Arm Type
    Experimental
    Arm Description
    First injection: 2% Lidocaine without adrenaline Second injection: Normal saline
    Intervention Type
    Procedure
    Intervention Name(s)
    Lidocaine/NSS
    Intervention Description
    First injection: subconjunctival 2% lidocaine without adrenaline 0.4 ml. before antibiotic injection Second injection (24 hours later): subconjunctival NSS 0.4 ml. before antibiotic injection
    Intervention Type
    Procedure
    Intervention Name(s)
    NSS/Lidocaine
    Intervention Description
    First injection: subconjunctival NSS 0.4 ml. before antibiotic injection Second injection (24 hours later): subconjunctival 2% lidocaine without adrenaline 0.4 ml. before antibiotic injection
    Primary Outcome Measure Information:
    Title
    Numeric rating scale
    Time Frame
    immediately after injection
    Secondary Outcome Measure Information:
    Title
    Side effects
    Time Frame
    24 hours after injection

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The corneal ulcer patients who are diagnosed by ophthalmologist and have 2 of 3 in these following features. corneal epithelial defect with stromal infiltration reaction in anterior chamber positive for bacteria or fungus The patients have to receive subconjunctival antibiotic injection twice at least. The patients must be informed consent. Exclusion Criteria: The patients who have history of allergy of local anesthetics, antibiotics or antifungal drugs. The patients who administered NSAIDs or weak opioids within 24 hours prior to subconjunctival antibiotic/antifungal injection. Unable to cooperate with the treatment. Pregnant women

    12. IPD Sharing Statement

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