Evaluation of Efficacy and Safety of Topical 1% Medroxyprogesterone in the Corneal Epithelium Healing After Photorefractive Keratectomy in Feiz Hospital, Isfahan, 2023

IR.MUI.MED.REC.1402.114

In this clinical trial, it is decided that 30 patients who are candidates for photorefractive keratectomy will receive a drop of prepared medroxyprogesterone randomly in one of their eyes, in addition to the routine antibiotic drop that is normally placed at the end of the procedure. Afterward, a bandage contact lens will be applied to both eyes, and the patients will receive routine post-procedure drops, including betamethasone and ciprofloxacin drops for both eyes. On the first, second, third, fourth, and fifth days after the operation, the patients will be examined, and the size of the epithelial defect in both eyes will be assessed using a slit lamp device. Additionally, the patients' pain levels in each eye will be evaluated using a questionnaire." The main question is: General purpose: Determining the efficacy and safety of 1% topical medroxyprogesterone in repairing the corneal epithelium after photorefractive keratectomy (PRK)

2023-04-21

2023-06-21

2023-07-06

Completed

Early phase I

74

Inclusion Criteria: * 1- Age above 18 years 2- Myopia and myopic astigmatism 3- The stability of the patient's refraction over the past year 4-- Not using contact lenses at least 3 weeks before the operation 5- Absence of history of KCN and any type of corneal ectasia in the patient himself or his first degree family 6- Full satisfaction and knowledge of patients to enter the plan 7- No history of previous eye surgery and eye trauma 8- Absence of active eye diseases, corneal dystrophy, retinal diseases, glaucoma, dry eyes of any degree. 9- Absence of systemic diseases that can potentially interfere with wound healing, including diabetes, vascular collagen diseases, and pregnancy. 10- Not taking inhaled or systemic steroids actively or within 3 months before the procedure Exclusion Criteria: 1. The patient's lack of consent to continue the study 2. Failure to visit the patient for follow-up

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 74, 'type': 'ACTUAL'}}

2023-08-02