KeratoconjunctivitisNCT06746467
Corneal Topography in Vernal Keratoconjunctivitis
An observational study of Keratoconjunctivitis, run by Assiut University at 1 site in Egypt.
Trial summary
To evaluate the corneal topographic changes in VKC patients using Pentacam and prevalence of KC development in VKC. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Keratoconjunctivitis
- What is being tested?
- pentacam
- Type of treatment
- Medical device
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients will be selected from primary clinic
Who may be able to join
- clinical diagnosis of vernal keratoconjunctivitis -
Who cannot join
- patients with corneal disease as corneal opacity, corneal dystrophy or degenerative changes patients with previous corneal surgery patients with ocular trauma.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
dalia mohamed mohamed, professer contact
Egypt1 site
Assiut University
Asyut
Assiut University, +201202961139, Monicabasem668@gmail.com
About this study
Official title: the Effect of Vernal Keratoconjunctivitis on Corneal Topographic Profiles
To evaluate the corneal topographic changes in VKC patients using Pentacam and prevalence of KC development in VKC.
Read the detailed description
Vernal keratoconjunctivitis (VKC) is a chronic allergic disease, with seasonal periods of exacerbation.VKC is characterized by itching, photophobia. white mucous discharge, lacrimation, foreign body sensation, and pain due to corneal involvement of shield ulcers. Corneal involvement in VKC involves injury to the superficial and basal epithelial layers and anterior stroma . Excessive eye rubbing and a slow release of matrix metalloproteinases penetrate the cornea in presence of chronic epithelial damage causing astigmatism and corneal ectasia . These changes may be undetected until advanced complications such as keratoconus(KC) with thinning and protrusion of cornea leading to myopia and astigmatism . These changes can be measured accurately by corneal topography, making it the gold standard in the screening of keratoconus and other corneal ectasias . Corneal topography is a method of computer-assisted examination of the cornea in which multiple concentric light rings are projected on cornea. Changes in corneal topography indices to be studied include changes in effective refeactivepower ,asphericity , corneal asymmetry index and visual performance . It is a non-invasive exploratory technique to analyse both qualitatively and quantitatively the morphology of the cornea . The Penta Cam is a cornea and anterior segment topography device, based on a rotating Scheimpflug camera. Its optical cross-sectional analysis that helps in imaging of anterior and posterior corneal surfaces which provides with fullpachymetric map and many other data such as corneal aberrometry and densitometry that allow early detection of ectasia.
- Conditions
- Keratoconjunctivitis
- Being tested
- pentacam
- Keywords
- corneal topography on vkc
- Medical subject headings
- Keratoconjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pentacamDevice
evaluate corneal changes by pentacam
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the corneal topographic changes in VKC patients using Pentacam
Measured: 1 year
Secondary outcomes (1)
prevalence of KC development in VKC
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study startJun 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for KeratoconjunctivitisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monica Basem Fayez, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746467
- Sponsor's protocol ID
- corneal topography in vkc
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dantas PE, Alves MR, Nishiwaki-Dantas MC. Topographic corneal changes in patients with vernal keratoconjunctivitis. Arq Bras Oftalmol. 2005 Sep-Oct;68(5):593-8. doi: 10.1590/s0004-27492005000500004. Epub 2005 Nov 28.
PubMed 16322853
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Vernal Keratoconjunctivitis on Corneal Topographic Profiles
- ClinicalTrials.gov ID
- NCT06746467
- Acronym / sponsor ID
- corneal topography in vkc
- Conditions
- Keratoconjunctivitis
- Keywords
- corneal topography on vkc
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Dec 2024 (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.
To evaluate the corneal topographic changes in VKC patients using Pentacam and prevalence of KC development in VKC.
Detailed description
Vernal keratoconjunctivitis (VKC) is a chronic allergic disease, with seasonal periods of exacerbation.VKC is characterized by itching, photophobia. white mucous discharge, lacrimation, foreign body sensation, and pain due to corneal involvement of shield ulcers. Corneal involvement in VKC involves injury to the superficial and basal epithelial layers and anterior stroma . Excessive eye rubbing and a slow release of matrix metalloproteinases penetrate the cornea in presence of chronic epithelial damage causing astigmatism and corneal ectasia . These changes may be undetected until advanced complications such as keratoconus(KC) with thinning and protrusion of cornea leading to myopia and astigmatism . These changes can be measured accurately by corneal topography, making it the gold standard in the screening of keratoconus and other corneal ectasias . Corneal topography is a method of computer-assisted examination of the cornea in which multiple concentric light rings are projected on cornea. Changes in corneal topography indices to be studied include changes in effective refeactivepower ,asphericity , corneal asymmetry index and visual performance . It is a non-invasive exploratory technique to analyse both qualitatively and quantitatively the morphology of the cornea . The Penta Cam is a cornea and anterior segment topography device, based on a rotating Scheimpflug camera. Its optical cross-sectional analysis that helps in imaging of anterior and posterior corneal surfaces which provides with fullpachymetric map and many other data such as corneal aberrometry and densitometry that allow early detection of ectasia.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients will be selected from primary clinic
Key inclusion criteria (1 listed)
- clinical diagnosis of vernal keratoconjunctivitis -
Key exclusion criteria (2 listed)
- patients with corneal disease as corneal opacity, corneal dystrophy or degenerative changes patients with previous corneal surgery patients with ocular trauma.
- -
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 |
|---|---|---|
| pentacamevaluate corneal changes by pentacam | Device | – |
Primary outcome
evaluate the corneal topographic changes in VKC patients using Pentacam
Time frame: 1 year
1 secondary outcome
prevalence of KC development in VKC
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Results publication: PubMed 16322853Dantas PE, Alves MR, Nishiwaki-Dantas MC. Topographic corneal changes in patients with vernal keratoconjunctivitis. Arq Bras Oftalmol. 2005 Sep-Oct;68(5):593-8. doi: 10.1590/s0004-27492005000500004. Epub 2005 Nov 28.
Related trials for Keratoconjunctivitis
Active, not recruitingPhase 2
Autologous Serum Obtained by a Closed-Circuit Collection Device
GVHD, Meibomian Gland Dysfunction (Disorder)
RecruitingPhase 3
An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED
Persistent Corneal Epithelial Defect
RecruitingPhase 3
An Efficacy and Safety Study of DFL24498 in the Treatment of AKC
Atopic Keratoconjunctivitis
Active, not recruiting
Lenticule Implantation and Autologous Serum New Approach in Treatment of Adenoviral Keratitis Disease
Adenoviral Keratoconjunctivitis
Not yet recruitingPhase 2
Safety and Efficacy of Topical Infliximab in Autoimmune Dry Eye Disease
Sjogren Syndrome, Sjogren Syndrome With Keratoconjunctivitis
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.
dalia mohamed mohamed, professer contact
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 Keratoconjunctivitis, run by Assiut 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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 24 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact monica basem fayez, doctor (+201202961139, Monicabasem668@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the corneal topographic changes in VKC patients using Pentacam (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06746467, which also lists 1 linked publication.
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 24 Dec 2024.