Effect of Various Treatment Modalities on Dendritic Vial Ulcer

Sponsor

Sohag University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05313828

Collaborator

(none)

Enrollment

Location

4.1

Anticipated Duration (Months)

9.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Corneal Ulcer	Drug: Acyclovir Drug: Tobramycin Drug: Fluorometholone Drug: Sodium Hyaluronate

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Effect of Various Treatment Modalities on Dendritic Vial Ulcer

Actual Study Start Date :

Mar 18, 2022

Anticipated Primary Completion Date :

Jun 28, 2022

Anticipated Study Completion Date :

Jul 20, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

healing of the epithelium [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients with epithelial viral ulcers

Exclusion Criteria:

patients with stromal keratitis patients with corneal opacity

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sohag University	Sohag		Egypt	82524

Sponsors and Collaborators

Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hany Mahmoud,MD, principal investigator, Sohag University

ClinicalTrials.gov Identifier:

NCT05313828

Other Study ID Numbers:

soh-med-22-02-28

First Posted:

Apr 6, 2022

Last Update Posted:

Apr 6, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022