Evaluation of Efficacy and Safety of Topical 1% Medroxyprogesterone in the Corneal Epithelium Healing After PRK

NCT ID: NCT05973253

Last Updated: 2023-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-21
• Study Completion Date: 2023-07-06

Brief Summary

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)

Detailed Description

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:

1. manifest and cycloplegic refraction

2. UCVA and BCVA

3. Pentacam(topographic imaging)

4. Examining the anterior and posterior segments of the eye with a slit lamp device Placed. Then, on the day of the surgery, in the refractive surgery operating room, the eyes are prepared . Anesthetizing drops of enstocaine are poured into the eyes. After removing the corneal epithelium, laser ablation is performed using the Technolas Teneo 317 device, and then mitomycin C is placed on the cornea based on the amount of ablation and then washed. At the end of the procedure, a contact lens bandage is placed on the eyes, and then a drop of the antibiotic ciprofloxacin is poured into the eyes. At this stage, a 1% medroxyprogesterone drop will be randomly poured into one of the eyes. After discharge, ciprofloxacin and betamethasone drops are routinely prescribed for the patient every 4 hours, and the patient returns for examination on the day after the operation and on the third and fifth days after the operation. (7) In each visit, the size of the corneal epithelial defect is measured by an ophthalmologist with a slit lamp examination as the largest length of the defect and the largest perpendicular length in millimeters. (2) Regarding the patient's pain and discomfort, a questionnaire is used to score the pain intensity by the patient (0: no pain, 1: mild pain, 2: moderate pain, 3: severe pain, 4: unbearable pain). (8) and the checklist includes information: pain intensity, optical size Defect, gender, age, ablation rate, and refractive error will be checked and recorded.

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.

Conditions

Photorefractive Keratectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

eyes that recieved medroxy progestrone at the end of surgery

eyes that received one drop of medroxy progesterone at the end of the photorefractive keratectomy(PRK)

Group Type: EXPERIMENTAL

prepared drop of medroxy progestrone acetat 1%

Intervention Type: 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.

eyes did not recieved moderxy progestrone

eyes that did not receive drop medroxy progesterone at the end of photorefractive keratectomy(PRK)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

prepared drop of medroxy progestrone acetat 1%

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.

Intervention Type: DRUG

Other Intervention Names

depo provera

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Isfahan Ophthalmology Research Center

NETWORK

Sponsor Role: collaborator

Isfahan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Alireza Peyman

Dr. Alireza Peyman

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alireza Peyman, MD

Role: STUDY_CHAIR

Isfahan ophthalmology research centre

Locations

Isfahan eyes research centre

Isfahan, , Iran

Isfahan Eye Research Center

Isfahan, , Iran

Countries

Iran

Other Identifiers

IR.MUI.MED.REC.1402.114

Identifier Type: -

Identifier Source: org_study_id