To study whether local application of Ultraviolet C radiation along with Methylene Blue eyedrops is beneficial and safe in compared to antimicrobial eye drops in treatment of corneal ulcers
- Conditions
- Corneal ulcer,
- Registration Number
- CTRI/2021/08/035870
- Lead Sponsor
- Divyajyoti Trust
- Brief Summary
This is a Prospective,Comparative, Double Arm, Open Label parallel group study comparing application of UVC rays plus Methylene Blue drops with standard of care in patients withinfectious Keratitis.
Patients 18 years(completed) and above with symptoms and signs of infectious keratitis asassessed by investigator, who provide consent for participation, and meet the inclusioncriteria and with no exclusion criteria as outlined in the protocol will beenrolled in the study.
After informedconsent form signature by the subject, data about full clinical history,physical examination, eye examination, and any current ongoing medications willbe recorded. The eye examinations will include- Slit Lamp Exam &Fluorescein staining, Corneal Scrapping for microbial tests, Anterior SegmentOptical Coherence Tomography (AS OCT), Pachymetry, specular microscopy, VisualAcuity. Pain and photophobia shall be assessed by use of a Visual AnalogueScale (VAS). For all females of childbearing potential, a Urine pregnancy testwill be done.
Eligible patientswill be randomized in a ratio of 1:1 to one of two study arms:
All patients will berequired to stay at the hospital for 72 hrs (3 days) for administration ofstudy treatments. Subjects will be followed up on Day 3 (Visit 2) beforedischarge. Further follow ups will be done on Day 7 (Visit 3), Day 10 (Visit4), Day 14 (Visit 5) and End of study visit on Day 30 (Visit 6). At each ofthese visits Slit lamp examination and fluorescein staining will be done. ASOCT, and Visual acuity will be repeated at Day 7, Day 10 and Day 14.
At End of study (Day30) visit, Vital signs will be recorded. Slit lamp and fluorescein staining,Visual acuity, pachymetry and AS OCT, shall be done.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 210
- 1.Subjects 18 years of age or older.
- 2.Patient exhibits clinical signs of corneal infiltrate or beginning corneal ulcer in at least one eye of suspected bacterial, fungal, viral or mixed (bacterial and fungal) origin.
- 3.Infiltrates and early ulcers up to a maximum 6mm in diameter.
- 4.No previous antibiotic/antifungal/ antiviral at least for a minimum of 48 hours from time of screening.
- 6.Patient willing to comply with all study procedures and be available for the duration of the study.
- 1.Patients with bilateral infectious keratitis/corneal ulcers 2.Suspicion of non-infectious keratitis, or acanthamoeba keratitis or sterile infiltrate.
- 3.Patients who cannot comply in the treatment or be monitored with frequent clinician controls as required in the study protocol.
- Patient not willing to stay in the hospital for first three days of treatment.
- 4.Corneal perforation 5.Descemetocele 6.Known or suspected G6PD deficiency 7.Allergic reaction / sensitivity to methylene blue 8.Pregnancy or breastfeeding 9.Immunosuppressed/immune-compromised patients.
- Patients on corticosteroids by any route for any other disease.
- Taking anti-inflammatory drugs for any other disease by any route.
- Taking any antibiotic for any other disease by any route.
- 11.Patients with diagnosed eczema (or atopic dermatitis) 12.Previous keratoplasty 13.Patients with monocular vision.
- Subjects with known history of clinically significant gastrointestinal, cardiovascular, hepatic, haematological, renal, respiratory, immunological, and neurological abnormalities, or disease which in opinion of investigator may interfere in the study compliance and assessments.
- Subjects who have participated in any other clinical trial ≤1 months prior to screening.
- Subjects who are employees or relatives of the study site staff.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of the time to heal the corneal ulcer in two treatment arms Day 7, Day 10, day 14 and Day 30
- Secondary Outcome Measures
Name Time Method To gather information on the safety of use of UVC plus Methylene Blue in subjects with Infectious keratitis including severity and frequency of adverse events in the study population. Day 7, day 10, day 14, Day 30
Trial Locations
- Locations (1)
Tejas Eye Hospital
🇮🇳Surat, GUJARAT, India
Tejas Eye Hospital🇮🇳Surat, GUJARAT, IndiaDr Uday GajiwalaPrincipal investigator9426125947divyajyoti.icare@gmail.com