Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients

March 10, 2019 updated by: Pramote Euasobhon, Mahidol University

Painless Subconjunctival Antibiotic and Antifungal Injection in Corneal Ulcer Patients.

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NSS/Lidocaine
First injection: Normal saline Second injection: 2% Lidocaine without adrenaline
Procedure: NSS/Lidocaine
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
Experimental: Lidocaine/NSS
First injection: 2% Lidocaine without adrenaline Second injection: Normal saline
Procedure: Lidocaine/NSS
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Numeric rating scale
Time Frame: immediately after injection
immediately after injection

Secondary Outcome Measures

Outcome Measure
Time Frame
Side effects
Time Frame: 24 hours after injection
24 hours after injection

Collaborators and Investigators

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

Sponsor

Mahidol University

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

June 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

November 11, 2008

First Submitted That Met QC Criteria

November 11, 2008

First Posted (Estimate)

November 13, 2008

Study Record Updates

Last Update Posted (Actual)

March 12, 2019

Last Update Submitted That Met QC Criteria

March 10, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SI 271/2008

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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