Pain After Photorefractive KeratectomyPhase 1NCT06752486
Assessment of Safety and Efficacy of Gabapentin After Surface Ablation, a Case Control Experimental Study
A Phase 1 study testing Giving post photorefractive keratectomy for pain relief in people with Pain After Photorefractive Keratectomy and VAS Will be Used to Assess Pain Postoperative, run by Research Institute of Ophthalmology, Egypt at 1 site in Egypt.
Trial summary
The current study aims at assessing the efficacy and safety of oral Gabapentin alone versus Diclofenac Potassium drugs for postoperative analgesia in patients undergoing surface ablation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain After Photorefractive Keratectomy, VAS Will be Used to Assess Pain Postoperative
- What is being tested?
- Giving post photorefractive keratectomy for pain relief
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to Jun 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients over 18 years old
- preoperative stable refraction for at least one-year,
- normal corneal tomography with expected postoperative flat K reading not less than 38D, and postoperative residual stromal bed not less than 350 μm.
Who cannot join
- Patients with preoperative corrected distance visual acuity (CDVA) of worse than 20/30
- amblyopic patients,
- patients with a history of previous ocular surgeries,
- herpetic eye infection, or corneal dystrophies.
- Patients with other ocular conditions e.g. uveal or retinal diseases, and glaucoma
- Diabetics,
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- Hypertensives,
- Kidney problems,
- breathing problems
- Adults older than 65 years.
- Previous allergy or adverse reaction to the used drugs.
- History of drug abuse or alcohol abuse problems
- History of mood problems, depression suicidal thoughts or behavior
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessment of Safety and Efficacy of Gabapentin for Postoperative Analgesia After Surface Ablation, Versus Diclofenac Potassium as a Gold Standard
The current study aims at assessing the efficacy and safety of oral Gabapentin alone versus Diclofenac Potassium drugs for postoperative analgesia in patients undergoing surface ablation.
Read the detailed description
To estimate the analgesic effect and pain severity after surface ablation with oral Gabapentin intake in comparison with Diclofenac Potassium, where Gabapentin could be a better analgesic medication after surface ablation
- Being tested
- Giving post photorefractive keratectomy for pain relief
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Giving post photorefractive keratectomy for pain reliefDrug
We plan to conduct a randomized prospective study to assess the efficacy and safety of oral Gabapentin versus oral Diclofenac Potassium for postoperative analgesia in adults undergoing surface ablation. The first group will be given gabapentin orally in a dose of 300mg Tid for 72 hours and the second group will be given oral diclofenac potassium 50mg Tid for 72 hours. The drugs will be administered starting from the first day postoperative.
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin Group | Active comparator | The first group will be given gabapentin orally in a dose of 300mg three times daily post photorefractive keratectomy for 72 hours Receives: Drug: Giving post photorefractive keratectomy for pain relief |
| Diclofenac potassium Group | Active comparator | the second group will be given oral diclofenac potassium 50mg Tid for 72 hours. The drugs will be administered starting from the first day postoperative.
All patients will be subjected to:
1. History taking including sociodemographics, medical illnesses, and prior surgery or anesthetic experiences.
2. Examination including assessment of vital data (heart rate, blood pressure, respiratory rate, level of consciousness, and respiratory examination. Receives: Drug: Giving post photorefractive keratectomy for pain relief |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain intensity will be evaluated with the visual analog scale (VAS) after surgery up to 72 hours.
pain assessment using Visual Analogue Scale
Measured: 72 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start1 Dec 2024
- Primary completion10 May 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain After 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Institute of Ophthalmology, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Moustafa Mohamed, Research Institute of Ophthalmology, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06752486
- Sponsor's protocol ID
- 25-2-23-3-6
- Status last verified
- Apr 2025
- First submitted
- 15 Dec 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: patient privacy
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Efficacy of Gabapentin for Postoperative Analgesia After Surface Ablation, Versus Diclofenac Potassium as a Gold Standard
- ClinicalTrials.gov ID
- NCT06752486
- Acronym / sponsor ID
- 25-2-23-3-6
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Research Institute of Ophthalmology, EgyptUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 10 May 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 30 Dec 2024 (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.
The current study aims at assessing the efficacy and safety of oral Gabapentin alone versus Diclofenac Potassium drugs for postoperative analgesia in patients undergoing surface ablation.
Detailed description
To estimate the analgesic effect and pain severity after surface ablation with oral Gabapentin intake in comparison with Diclofenac Potassium, where Gabapentin could be a better analgesic medication after surface ablation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin Group | Active comparator | Drug: Giving post photorefractive keratectomy for pain reliefThe first group will be given gabapentin orally in a dose of 300mg three times daily post photorefractive keratectomy for 72 hours |
| Diclofenac potassium Group | Active comparator | Drug: Giving post photorefractive keratectomy for pain reliefthe second group will be given oral diclofenac potassium 50mg Tid for 72 hours. The drugs will be administered starting from the first day postoperative. All patients will be subjected to: 1. History taking including sociodemographics, medical illnesses, and prior surgery or anesthetic experiences. 2. Examination including assessment of vital data (heart rate, blood pressure, respiratory rate, level of consciousness, and respiratory examination. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients over 18 years old
- preoperative stable refraction for at least one-year,
- normal corneal tomography with expected postoperative flat K reading not less than 38D, and postoperative residual stromal bed not less than 350 μm.
Key exclusion criteria (13 listed)
- Patients with preoperative corrected distance visual acuity (CDVA) of worse than 20/30
- amblyopic patients,
- patients with a history of previous ocular surgeries,
- herpetic eye infection, or corneal dystrophies.
- Patients with other ocular conditions e.g. uveal or retinal diseases, and glaucoma
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 |
|---|---|---|
| Giving post photorefractive keratectomy for pain reliefWe plan to conduct a randomized prospective study to assess the efficacy and safety of oral Gabapentin versus oral Diclofenac Potassium for postoperative analgesia in adults undergoing surface ablation. The first group will be given gabapentin orally in a dose of 300mg Tid for 72 hours and the second group will be given oral diclofenac potassium 50mg Tid for 72 hours. The drugs will be administered starting from the first day postoperative. | Drug | Diclofenac potassium Group, Gabapentin Group |
Primary outcome
Postoperative Pain intensity will be evaluated with the visual analog scale (VAS) after surgery up to 72 hours.
Time frame: 72 hours postoperative
pain assessment using Visual Analogue Scale
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Individual participant dataSharing planned: Undecided. patient privacy
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Giving post photorefractive keratectomy for pain relief in people with Pain After Photorefractive Keratectomy and VAS Will be Used to Assess Pain Postoperative, run by Research Institute of Ophthalmology, Egypt at 1 site in Egypt.
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 13 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: looking for participants now, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dina Moustafa M Ali, MD (01113981021, dina.moustafa.ali@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain intensity will be evaluated with the visual analog scale (VAS) after surgery up to 72 hours. (time frame: 72 hours postoperative). 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 30 Apr 2025.