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| Name | Class |
|---|---|
| Isfahan Ophthalmology Research Center | NETWORK |
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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)
Patients who have referred for refractive surgery to correct myopia and myopia-stigmatism first undergo complete examinations that are required before the procedure, which includes the following examinations:
The patient and the examiner do not know about the eye in which medroxyprogesterone drops were used at the end of the procedure.
Medroxyprogesterone drops are made by a pharmacologist under sterile conditions and delivered the day before the operation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eyes that recieved medroxy progestrone at the end of surgery | Experimental | eyes that received one drop of medroxy progesterone at the end of the photorefractive keratectomy(PRK) |
|
| eyes did not recieved moderxy progestrone | No Intervention | eyes that did not receive drop medroxy progesterone at the end of photorefractive keratectomy(PRK) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prepared drop of medroxy progestrone acetat 1% | Drug | In 37 patients who are candidates for photorefractive keratectomy, at the end of the procedure, in one eye randomly, in addition to the antibiotic drop that is routinely placed at the end of the procedure, a drop of prepared medroxyprogesterone is also placed. Then, a bandage contact lens is placed on the eyes, and the patient receives the routine post-procedure drops that include betamethasone and ciprofloxacin drops for both eyes. |
| Measure | Description | Time Frame |
|---|---|---|
| Determining the efficacy and safety of 1% topical medroxyprogesterone in repairing the corneal epithelium after photorefractive keratectomy (PRK) | Determining the efficacy and safety of 1% topical medroxyprogesterone in repairing the corneal epithelium after photorefractive keratectomy (PRK) | 3 months |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Alireza Peyman, MD | Isfahan ophthalmology research centre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isfahan eyes research centre | Isfahan | 0098 | Iran | |||
| Isfahan Eye Research Center |
Will be shared upon request
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| ID | Term |
|---|---|
| D017258 | Medroxyprogesterone Acetate |
| ID | Term |
|---|---|
| D008525 | Medroxyprogesterone |
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
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|
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| Isfahan |
| 81746-73461 |
| Iran |
| D011283 |
| Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |