Corneal UlcerNCT05313828
Effect of Various Treatment Modalities on Dendritic Vial Ulcer
An observational study of Corneal Ulcer, run by Sohag University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Ulcer
- What is being tested?
- Acyclovir, Tobramycin and Fluorometholone
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Mar 2022to 20 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients suffering from epithelial viral keratitis
Who may be able to join
- patients with epithelial viral ulcers
- -
Who cannot join
- patients with stromal keratitis patients with corneal opacity
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag University
Sohag, 82524
Hany Mahmoud, 01024368111, drhanymahmoud@gmail.com
About this study
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.
- Conditions
- Corneal Ulcer
- Being tested
- Acyclovir, Tobramycin, Fluorometholone, Sodium Hyaluronate
- Medical subject headings
- Corneal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcyclovirDrug
acyclovir 4 times /day
TobramycinDrug
tobramycin 4 times /day
FluorometholoneDrug
Fluorometholone 4 times/ day
Sodium HyaluronateDrug
Sodium Hyaluronate 4 times/day
| Study group | Role | What they receive |
|---|---|---|
| group 1' | patients with viral ulcers will receive antiviral medication with antibiotics Receives: Drug: Acyclovir; Drug: Tobramycin | |
| group 2 | patients with viral ulcers will receive antiviral medication, tear substitutes with antibiotics Receives: Drug: Acyclovir; Drug: Tobramycin; Drug: Sodium Hyaluronate | |
| group 3 | patients with viral ulcers will receive antiviral medication, weak steroids(at the same time) with antibiotics Receives: Drug: Acyclovir; Drug: Tobramycin; Drug: Fluorometholone | |
| group 4 | patients with viral ulcers will receive antiviral medication with antibiotics followed by weak steroid after epithelial healing Receives: Drug: Acyclovir; Drug: Tobramycin; Drug: Fluorometholone |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing of the epithelium
the epithelial healing assessed with flourescin stain and measured by slit lamp scale in millimetres and compared with pre treatment epithelial defect
Measured: 10 days follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start18 Mar 2022
- Primary completion28 Jun 2022 (estimated)
- Study completion20 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal UlcerStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Mahmoud,MD, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313828
- Sponsor's protocol ID
- soh-med-22-02-28
- Status last verified
- Apr 2022
- First submitted
- 26 Mar 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Various Treatment Modalities on Dendritic Vial Ulcer
- ClinicalTrials.gov ID
- NCT05313828
- Acronym / sponsor ID
- soh-med-22-02-28
- Conditions
- Corneal Ulcer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 28 Jun 2022 (estimated)
- Study completion
- 20 Jul 2022 (estimated)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 1' | – | Drug: Acyclovir, Drug: Tobramycinpatients with viral ulcers will receive antiviral medication with antibiotics |
| group 2 | – | Drug: Acyclovir, Drug: Tobramycin, Drug: Sodium Hyaluronatepatients with viral ulcers will receive antiviral medication, tear substitutes with antibiotics |
| group 3 | – | Drug: Acyclovir, Drug: Tobramycin, Drug: Fluorometholonepatients with viral ulcers will receive antiviral medication, weak steroids(at the same time) with antibiotics |
| group 4 | – | Drug: Acyclovir, Drug: Tobramycin, Drug: Fluorometholonepatients with viral ulcers will receive antiviral medication with antibiotics followed by weak steroid after epithelial healing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients suffering from epithelial viral keratitis
Key inclusion criteria (2 listed)
- patients with epithelial viral ulcers
- -
Key exclusion criteria (1 listed)
- patients with stromal keratitis patients with corneal opacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acycloviracyclovir 4 times /day | Drug | group 1', group 2, group 3, group 4 |
| Tobramycintobramycin 4 times /day | Drug | group 1', group 2, group 3, group 4 |
| FluorometholoneFluorometholone 4 times/ day | Drug | group 3, group 4 |
| Sodium HyaluronateSodium Hyaluronate 4 times/day | Drug | group 2 |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Ulcer, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hany Mahmoud (00201024368111, drhanymahmoud@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healing of the epithelium (time frame: 10 days follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.