Treatment of Ocular Surface Inflammations
Treatment of Ocular Surface Inflammations With 1% Cyclosporine (Ikervis) Eye Drops
The goal of this clinical trial is to learn if topical Cyclosporine 1% works to treat severe allergic ocular surface inflammation in pediatric population. The study will evaluate the efficacy and safety of topical Cyclosporine 1%.
The main questions it aims to answer are:
Does topical Cyclosporine 1% lower the number of times participants need to use a rescue steroid? What medical problems do participants have when taking topical Cyclosporine 1%?
Participants will:
Take topical Cyclosporine 1% every day for months. Visit the clinic once every 2-6 weeks for checkups and tests. Keep a diary of their symptoms and the number of times they use a rescue medication. spelling errors/typos and update as appropriate.
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
The goal of this clinical trial is to evaluate the efficacy and safety of topical Cyclosporine 1% for the treatment of severe allergic ocular surface inflammation in the pediatric population.
The main questions this study aims to answer are:
Does topical Cyclosporine 1% reduce the frequency of rescue steroid use? What adverse events occur during treatment with topical Cyclosporine 1%?
Patients with severe ocular surface inflammation who are prescribed topical Cyclosporine 1% as part of routine clinical care will be prospectively observed. Participants will receive topical Cyclosporine 1% daily for several months and attend follow-up visits every 2 to 6 weeks. During these visits, slit-lamp examination, non-invasive tear film evaluation, eyelid morphology assessment, and anterior segment evaluation will be performed. Participants will also maintain a diary documenting symptoms and the frequency of rescue medication use throughout the study period.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Lim Lu Hyoun
- Numer telefonu: +3614591500
- E-mail: luhyoun21c@gmail.com
Lokalizacje studiów
-
-
Pest County
-
Budapest, Pest County, Węgry, 1085
- Rekrutacyjny
- Semmelweis University Department of Ophthalmology
-
Kontakt:
- Amarilla Barcsay-Veres, MD.PhD.
- Numer telefonu: 003614591500
- E-mail: veres.amarilla@semmelweis.hu
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- ocular surface inflammatory disease cornea inflammation -keratitis
Exclusion Criteria:
- eye surgery within 1 year, lack of fitness for the objective ocular surface measurments
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
Chronic ocular allergic inflammation
Topical 1% cyclosporin applied for treatment Chronic ocular allergic inflammation
|
Dosage may differ from severe dry eye indication
|
|
Blepharokeratoconjunctivitis
Blepharokeratoconjunctivitis patients who have accompaining blepharitis and ocular surface inflammation as well
|
Dosage may differ from severe dry eye indication
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
subjective ocular symptoms
Ramy czasowe: Baseline to 36 months
|
Subjective ocular symptoms, including tearing, photosensitivity, itching and discharge, were quantified on a visual analogue scale (VAS) ranging from 0 to 10.
The maximum score was 40, with the most severe symptom score being.
Reference: Bonini, S., Sacchetti, M., Mantelli, F. & Lambiase, A. Clinical grading of vernal keratoconjunctivitis. Curr.
Opin.
Allergy Clin.
Immunol.
7, 436-441 (2007).
|
Baseline to 36 months
|
|
Frequency of Rescue Steroid Use
Ramy czasowe: Baseline to 36 months
|
Number of rescue topical corticosteroid treatments required during the study period.
|
Baseline to 36 months
|
|
Oxford Grading Scale Score for Ocular Surface Staining
Ramy czasowe: Baseline to 36 months
|
Severity of allergic ocular surface inflammation will be assessed by slit-lamp examination using the Oxford Grading Scale for ocular surface staining.
Scores range from 0 to 5, with higher scores indicating more severe ocular surface staining and worse inflammation.
|
Baseline to 36 months
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Non-Invasive Tear Break-Up Time (NIBUT)
Ramy czasowe: Baseline to 36 months
|
Tear film stability will be assessed using non-invasive tear break-up time (NIBUT) measured with the LacryDiag ocular surface analyzer, a non-contact diagnostic device that evaluates tear film dynamics using Placido ring-based corneal topography. Higher values indicate greater tear film stability. Unit : seconds |
Baseline to 36 months
|
|
Lipid Layer Thickness (LLT) Grade
Ramy czasowe: Baseline to 36 months
|
Lipid layer thickness (LLT) will be assessed using interferometry with the LacryDiag ocular surface analyzer.
LLT is recorded using a semi-quantitative grading scale ranging from 0 to 7 based on interferometric patterns of the tear film lipid layer.
Higher grades indicate a thicker lipid layer and improved tear film stability.
Scale Range 0-7
|
Baseline to 36 months
|
|
Tear Meniscus Height (TMH)
Ramy czasowe: Baseline to 36 months
|
Tear meniscus height (TMH) will be measured using the LacryDiag ocular surface analyzer.
TMH is an objective measure of tear volume obtained from infrared imaging of the lower tear meniscus.
Higher values indicate greater tear volume.
Unit : Millimeters (mm)
|
Baseline to 36 months
|
|
Meibomian Gland Dropout Percentage
Ramy czasowe: Baseline to 36 months
|
Meibomian gland dropout will be assessed using infrared meibography obtained with the LacryDiag ocular surface analyzer.
The proportion of meibomian gland loss within the tarsal area will be automatically calculated by the device and expressed as a percentage.
Higher percentages indicate greater meibomian gland loss and a worse outcome.
Unit : Percent (%)
|
Baseline to 36 months
|
|
Meibomian Gland Morphological Abnormality Score
Ramy czasowe: Baseline to 36 months
|
Meibomian gland morphology will be assessed using infrared meibography obtained with the LacryDiag ocular surface analyzer.
Four morphological abnormalities will be evaluated: tortuosity, shortening, overlapping, and hooked glands.
Each abnormality will be recorded as present or absent using a binary scoring system.
The total morphological abnormality score will range from 0 to 4, with higher scores indicating a greater number of meibomian gland morphological abnormalities and a worse outcome.
Scale range : 0-4
|
Baseline to 36 months
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Amarilla Barcsay-Veres, MD, Semmelweis University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- NNGYK/23414-1/2025
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .