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

NCT05973253 | Completed Phase 2

• 1 other identifier: IR.MUI.MED.REC.1402.114
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

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)

Conditions

Photorefractive Keratectomy

Keywords

PRK; MEDROXY PROGESTRONE

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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)

Drug: prepared drop of medroxy progestrone acetat 1%

eyes did not recieved moderxy progestrone

NO INTERVENTION

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

Interventions

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.

Also known as: depo provera

eyes that recieved medroxy progestrone at the end of surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Absence of systemic diseases that can potentially interfere with wound healing, including diabetes, vascular collagen diseases, and pregnancy.
• Not taking inhaled or systemic steroids actively or within 3 months before the procedure

You may not qualify if:

• The patient's lack of consent to continue the study
• Failure to visit the patient for follow-up

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead
• Isfahan Ophthalmology Research Center: collaborator

Study Sites (2)

Isfahan eyes research centre

Isfahan, 0098, Iran

Location

Isfahan Eye Research Center

Isfahan, 81746-73461, Iran

Location

MeSH Terms

Interventions

Medroxyprogesterone Acetate

Intervention Hierarchy (Ancestors)

Medroxyprogesterone; Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Alireza Peyman, MD

  Isfahan ophthalmology research centre

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Alireza Peyman

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 2, 2023
• Study Start: April 21, 2023
• Primary Completion: June 21, 2023
• Study Completion: July 6, 2023
• Last Updated: August 2, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IR (2)