Photorefractive KeratectomyPhase 2/3NCT05973253
Evaluation of Efficacy and Safety of Topical 1% Medroxyprogesterone in the Corneal Epithelium Healing After PRK
A Phase 2/3 study testing prepared drop of medroxy progestrone acetat 1% in people with Photorefractive Keratectomy, run by Isfahan University of Medical Sciences at 2 sites in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Photorefractive Keratectomy
- What is being tested?
- prepared drop of medroxy progestrone acetat 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesIran
- Study dates
- 21 Apr 2023to 6 Jul 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- The patient's lack of consent to continue the study
- Failure to visit the patient for follow-up
Trial locations and contacts
2 sites in 1 country.
Iran2 sites
Isfahan eyes research centre
Isfahan, 0098
Isfahan Eye Research Center
Isfahan, 81746-73461
About this study
Official title: Evaluation of Efficacy and Safety of Topical 1% Medroxyprogesterone in the Corneal Epithelium Healing After Photorefractive Keratectomy in Feiz Hospital, Isfahan, 2023
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)
Read the 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:
- manifest and cycloplegic refraction
- UCVA and BCVA
- Pentacam(topographic imaging)
- 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
- Being tested
- prepared drop of medroxy progestrone acetat 1%
- Keywords
- PRK, MEDROXY PROGESTRONE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prepared drop of medroxy progestrone acetat 1%Drug
Also called depo provera
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start21 Apr 2023
- Primary completion21 Jun 2023
- Study completion6 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photorefractive KeratectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Isfahan Ophthalmology Research Center
- Responsible party
- Principal investigator, Alireza Peyman, Isfahan University of Medical Sciences
- Investigators
- Alireza Peyman, MD, Study chair, Isfahan ophthalmology research centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973253
- Sponsor's protocol ID
- IR.MUI.MED.REC.1402.114
- Status last verified
- Jul 2023
- First submitted
- 26 Jul 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will be shared upon request
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Topical 1% Medroxyprogesterone in the Corneal Epithelium Healing After Photorefractive Keratectomy in Feiz Hospital, Isfahan, 2023
- ClinicalTrials.gov ID
- NCT05973253
- Acronym / sponsor ID
- IR.MUI.MED.REC.1402.114
- Conditions
- Photorefractive Keratectomy
- Keywords
- PRK, MEDROXY PROGESTRONE
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Collaborators
- Isfahan Ophthalmology Research Center
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- manifest and cycloplegic refraction
- UCVA and BCVA
- Pentacam(topographic imaging)
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eyes that recieved medroxy progestrone at the end of surgery | Experimental | Drug: prepared drop of medroxy progestrone acetat 1%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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- The patient's lack of consent to continue the study
- Failure to visit the patient for follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prepared drop of medroxy progestrone acetat 1%Also: depo proveraIn 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. | Drug | eyes that recieved medroxy progestrone at the end of surgery |
Primary outcome
Determining the efficacy and safety of 1% topical medroxyprogesterone in repairing the corneal epithelium after photorefractive keratectomy (PRK)
Time frame: 3 months
Determining the efficacy and safety of 1% topical medroxyprogesterone in repairing the corneal epithelium after photorefractive keratectomy (PRK)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: No. Will be shared upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alireza Peyman, MD study chair
Isfahan ophthalmology research centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing prepared drop of medroxy progestrone acetat 1% in people with Photorefractive Keratectomy, run by Isfahan University of Medical Sciences at 2 sites in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining the efficacy and safety of 1% topical medroxyprogesterone in repairing the corneal epithelium after photorefractive keratectomy (PRK) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.