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IRCT20231219060471N1 IRCT 2024-02-16 Tehran University of Medical Sciences The comparison efficacy and safety of topical caspofungin ۰.5% and topical voriconazole 1% in fungal keratitis The comparison efficacy and safety of topical caspofungin ۰.5% and topical voriconazole 1% in fungal keratitis 2024-01-19 anticipated 20 Complete https://irct.ir/trial/74665 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study uses both block and individual randomization methods, based on random number tables. The samples are divided into two groups (A and B), with 10 randomly selected samples in each group, based on the randomization tables. Additionally, all sequences are randomized, Blinding description: The patients participating in this study will be treated by an expert ophthalmologist who will not interfere with their selection process. Patients will be selected randomly based on a randomization table. The main author responsible for evaluating the data will keep blind. Additionally, a data safety and monitoring committee will analyze the study while being blind to the patient's information. All patients will be informed of the study but will not know which medication they are receiving and will remain blind. 2-3 FUNGAL KERATITIS. Intervention 1: Intervention group: For the treatment of fungal keratitis, topical caspofungin 0.5% will be administered. A vial of caspofungin 50 mg is to be diluted with 10.5 cc of Ringer Lactate, and the drops should be instilled every hour for 48 hours. The frequency of administration can then be tapered based on the patient's clinical response. Patients will need to visit the clinic on days 7, 14, and 30 then 3rd month for follow-up appointments. Intervention 2: A control group of patients with fungal keratitis will be treated with topical voriconazole 1%. The voriconazole will be diluted with 20 cc of Ringer lactate. Each patient will receive a drop every hour for 48 hours, after which the dosage will be tapered based on clinical response. Patients will be required to visit the clinic on days 7, 14, 30, and 30 months after the treatment for evaluation of clinical response and to monitor for any clinical and systemic side effects. Yes - There is a plan to make this available What will be shared: all informations When: dates availability after publication To whom: researchers work at academic centers Conditions: additional similar patients dates Where to obtain: corresponding researcher How to obtain: six months Comments:
public Mehran Zarei Ghanavati
Farabi Eye Hospital. Qazvin Square, South Karegar street
Tehran Iran (Islamic Republic of) 1336616351 +98 21 5542 1080 m-zareigh@sina.tums.ac.ir Tehran University of Medical Sciences scientific Mehran Zarei Ghanavati
Farabi Eye Hospital. Qazvin square ,South Karegar street
Tehran Iran (Islamic Republic of) 1336616351 +98 21 5542 1080 m-zareigh@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Smear or culture positive fungal keratitis or fungal keratitis with negative smear or culture which is diagnosed by confocal scan Corneal ulcer with a 5mm maximum diameter, involving 4 mm of the center of the cornea, and extending less than 5۰% of the corneal stromal depth 18 years no limit Both B35-B49,H1 Mycoses, Disorders of sclera, cornea, iris and ciliary body, Disorders of sclera and cornea in diseases classified elsewhere Treatment - Drugs Treatment - Drugs Intervention group: For the treatment of fungal keratitis, topical caspofungin 0.5% will be administered. A vial of caspofungin 50 mg is to be diluted with 10.5 cc of Ringer Lactate, and the drops should be instilled every hour for 48 hours. The frequency of administration can then be tapered based on the patient's clinical response. Patients will need to visit the clinic on days 7, 14, and 30 then 3rd month for follow-up appointments. A control group of patients with fungal keratitis will be treated with topical voriconazole 1%. The voriconazole will be diluted with 20 cc of Ringer lactate. Each patient will receive a drop every hour for 48 hours, after which the dosage will be tapered based on clinical response. Patients will be required to visit the clinic on days 7, 14, 30, and 30 months after the treatment for evaluation of clinical response and to monitor for any clinical and systemic side effects. The efficacy and safety of topical caspofungin 0.5% and topical voriconazole 1% will be compared in treating fungal keratitis. Clinical response, scar formation, corneal scar size, visual acuity outcomes, and size and depths of corneal infiltration will also be evaluated. Timepoint: An ophthalmic examination will be conducted daily during hospitalization, on the 7th, 14th, and 30th days, as well as on the 3rd month. Method of measurement: A clinical examination will be conducted by an expert ophthalmologist. The examination will involve the use of a slit-lamp biomicroscopy to detect clinical response and measure the size and depth of infiltration using a caliper. The size and depth of the corneal scar will also be detected with a slit lamp and measured using a caliper. All clinical responses will be recorded by slit-lamp photography in each examination. Tehran University of Medical Sciences Tehran University of Medical Sciences Tehran University of Medical Sciences Approved 2023-12-04 Ethics committee of Tehran University of Medical Sciences Farabi Eye Hospital, Square Qazvin, South Karegar street Tehran Tehran Iran (Islamic Republic of)