Vernal KeratoconjunctivitisNCT06913790
Evaluation of Central Corneal Thickness in Patients With Vernal Keratoconjunctivitis Using Topical Steroids
An observational study of Vernal Keratoconjunctivitis, run by Superior University at 1 site in Pakistan.
Trial summary
This prospective observational cohort study aims to assess changes in central corneal thickness (CCT) in vernal keratoconjunctivitis (VKC) patients using topical steroids. Data will be collected from tertiary care hospitals such as Al-Mustafa eye hospital and Jinnah Hospital, Lahore. Read more about this study
- Who is it for?
- Ages 5 to 25 years
- Conditions the study is for
- Vernal Keratoconjunctivitis
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2025to 20 Feb 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 5 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This prospective observational cohort study aims to assess changes in central corneal thickness (CCT) in vernal keratoconjunctivitis (VKC) patients using topical steroids. Data will be collected from tertiary care hospitals such as Al-Mustafa eye hospital and Jinnah Hospital, Lahore
Who may be able to join
- Young adults aged between 5-25 years
- Confirmed diagnosis of VKC
- Currently prescribe topical steroid e.g, dexamethasone, prednisolone
- No prior history of corneal surgery or trauma
- Willing to attend follow-up visits and comply with the treatment protocol.
Who cannot join
- History of ocular surgery or trauma
- Presence of other corneal pathologies (e.g., Keratoconus)
- Systemic immunosuppressant use or history of systemic steroid use in the past 06 months
- Use of other medications that could influence corneal thickness e.g, antiglaucoma drugs
- Contact lens use within 1 month prior to the study
- Severe dry eye or another ocular surface disease"
Trial locations and contacts
1 site in 1 country.
About this study
This prospective observational cohort study aims to assess changes in central corneal thickness (CCT) in vernal keratoconjunctivitis (VKC) patients using topical steroids. Data will be collected from tertiary care hospitals such as Al-Mustafa eye hospital and Jinnah Hospital, Lahore.
Read the detailed description
A total of 34 participants, including an adjustment for a 10% dropout rate, will be recruited using purposive sampling. The study will last six months. Eligible participants (aged 5-25 years) must have a confirmed VKC diagnosis and be on topical steroids, with exclusions for prior ocular surgery, systemic steroid use, and contact lens wear. Baseline assessments will include demographic data, VKC severity, and CCT measurements via pachymetry and optical coherence tomography. Follow-up evaluations at one and three months will track CCT changes. A paired t-test will compare baseline and follow-up measurements. This study will help understand the impact of topical steroids on CCT in VKC patients.
- Conditions
- Vernal Keratoconjunctivitis
- Medical subject headings
- Conjunctivitis, Allergic
What is being measured
The primary outcome is the main question the study is designed to answer.
Slit Lamp Test
A slit lamp exam, a common eye test, uses a microscope and a focused light beam to examine the front and back of the eye, aiding in the diagnosis of various conditions, and often involves scoring or grading for certain aspects like cell and flar
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start20 Mar 2025
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vernal KeratoconjunctivitisStudies of the same condition, open and under way.
- More trials run by Superior 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
- Retrospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913790
- Sponsor's protocol ID
- MSRSW/Batch-Fall23/808
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Central Corneal Thickness in Patients With Vernal Keratoconjunctivitis Using Topical Steroids
- ClinicalTrials.gov ID
- NCT06913790
- Acronym / sponsor ID
- MSRSW/Batch-Fall23/808
- Conditions
- Vernal Keratoconjunctivitis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 6 Apr 2025 (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.
This prospective observational cohort study aims to assess changes in central corneal thickness (CCT) in vernal keratoconjunctivitis (VKC) patients using topical steroids. Data will be collected from tertiary care hospitals such as Al-Mustafa eye hospital and Jinnah Hospital, Lahore.
Detailed description
A total of 34 participants, including an adjustment for a 10% dropout rate, will be recruited using purposive sampling. The study will last six months. Eligible participants (aged 5-25 years) must have a confirmed VKC diagnosis and be on topical steroids, with exclusions for prior ocular surgery, systemic steroid use, and contact lens wear. Baseline assessments will include demographic data, VKC severity, and CCT measurements via pachymetry and optical coherence tomography. Follow-up evaluations at one and three months will track CCT changes. A paired t-test will compare baseline and follow-up measurements. This study will help understand the impact of topical steroids on CCT in VKC patients.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This prospective observational cohort study aims to assess changes in central corneal thickness (CCT) in vernal keratoconjunctivitis (VKC) patients using topical steroids. Data will be collected from tertiary care hospitals such as Al-Mustafa eye hospital and Jinnah Hospital, Lahore
Key inclusion criteria (5 listed)
- Young adults aged between 5-25 years
- Confirmed diagnosis of VKC
- Currently prescribe topical steroid e.g, dexamethasone, prednisolone
- No prior history of corneal surgery or trauma
- Willing to attend follow-up visits and comply with the treatment protocol.
Key exclusion criteria (6 listed)
- History of ocular surgery or trauma
- Presence of other corneal pathologies (e.g., Keratoconus)
- Systemic immunosuppressant use or history of systemic steroid use in the past 06 months
- Use of other medications that could influence corneal thickness e.g, antiglaucoma drugs
- Contact lens use within 1 month prior to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Slit Lamp Test
Time frame: 12 Months
A slit lamp exam, a common eye test, uses a microscope and a focused light beam to examine the front and back of the eye, aiding in the diagnosis of various conditions, and often involves scoring or grading for certain aspects like cell and flar
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 6 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Vernal Keratoconjunctivitis
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
3% Diquafosol Ophthalmic Solution for Active Moderate-to-Severe Vernal Keratoconjunctivitis
Vernal Keratoconjunctivitis
RecruitingPhase 2
A Study to Compare the Effectiveness and Safety of T1695 Versus Ciclosporin in Participants With Moderate to Severe Vernal Keratoconjunctivitis
Moderate to Severe Vernal Keratoconjunctivitis
Not yet recruiting
Tacrolimus Eye Drops in Treatment of Vernal Keratoconjunctivitis
Vernal Keratoconjunctivitis
Not yet recruitingPhase 1
Efficacy and Safety of Oral Probiotics on Ocular Symptoms and Gut Microbiome of Children with Vernal Keratoconjunctivitis
Probiotic, Ocular Surface Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Vernal Keratoconjunctivitis, run by Superior University at 1 site in Pakistan.
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 5 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2025. 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 Pakistan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Slit Lamp Test (time frame: 12 Months). 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 2025.