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
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
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
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
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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Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients
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