Effect of Various Treatment Modalities on Dendritic Vial Ulcer

April 4, 2022 updated by: Hany Mahmoud,MD, Sohag University

Eye infection is a prevalent problem in primary care and remains a crucial healthcare concern. According to the American Academy of Ophthalmology (AAO), herpes simplex virus (HSV) keratitis (HSK) is the leading cause of infectious blindness worldwide . HSK is defined as a corneal inflammatory condition caused by the HSV infection . The global incidence of herpetic keratitis is estimated at 1.5 million per year, resulting in 40,000 new cases of severe visual impairment associated with corneal scarring and opacification . HSV type I (HSV-1) is by far the most predominant causative pathogen of eye infections]. HSV-1 is also known for causing orolabial herpes, HSV folliculitis, herpes gladiatorum, herpetic whitlow, and eczema herpeticum . HSV can be transferred to the eye by touching an active lesion and then the eye. The National Health and Nutrition Evaluation revealed a seroprevalence of HSV-1 in 53.9% of 14-49 year olds, and 90% of adults 50 years or older , indicating that the majority of the population has been exposed to this virus thus are at risk of developing HSK.

In this study we evaluate the efficacy of different treatment modalities on viral keratitis HSK.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Sampling Method

Probability Sample

Study Population

patients suffering from epithelial viral keratitis

Description

Inclusion Criteria:

patients with epithelial viral ulcers

-

Exclusion Criteria:

  • patients with stromal keratitis patients with corneal opacity

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group 1'
patients with viral ulcers will receive antiviral medication with antibiotics
Drug: Acyclovir
acyclovir 4 times /day
Drug: Tobramycin
tobramycin 4 times /day
group 2
patients with viral ulcers will receive antiviral medication, tear substitutes with antibiotics
Drug: Acyclovir
acyclovir 4 times /day
Drug: Tobramycin
tobramycin 4 times /day
Drug: Sodium Hyaluronate
Sodium Hyaluronate 4 times/day
group 3
patients with viral ulcers will receive antiviral medication, weak steroids(at the same time) with antibiotics
Drug: Acyclovir
acyclovir 4 times /day
Drug: Tobramycin
tobramycin 4 times /day
Drug: Fluorometholone
Fluorometholone 4 times/ day
group 4
patients with viral ulcers will receive antiviral medication with antibiotics followed by weak steroid after epithelial healing
Drug: Acyclovir
acyclovir 4 times /day
Drug: Tobramycin
tobramycin 4 times /day
Drug: Fluorometholone
Fluorometholone 4 times/ day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
healing of the epithelium
Time Frame: 10 days follow up
the epithelial healing assessed with flourescin stain and measured by slit lamp scale in millimetres and compared with pre treatment epithelial defect
10 days follow up

Collaborators and Investigators

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

Sponsor

Sohag 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 (Actual)

March 18, 2022

Primary Completion (Anticipated)

June 28, 2022

Study Completion (Anticipated)

July 20, 2022

Study Registration Dates

First Submitted

March 26, 2022

First Submitted That Met QC Criteria

April 4, 2022

First Posted (Actual)

April 6, 2022

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • soh-med-22-02-28

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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Locations

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