Evaluating Gabapentin for Pain Relief After Eye Surgery
Assessment of Safety and Efficacy of Gabapentin for Postoperative Analgesia After Surface Ablation, Versus Diclofenac Potassium as a Gold Standard
This study is testing if Gabapentin can help people feel less pain after eye surgery compared to a common pain medication called Diclofenac Potassium.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Research Institute of Ophthalmology, Egypt Academic / other |
| Locations | 1 site (Giza) |
| Trial ID | NCT06752486 on ClinicalTrials.gov |
What this trial studies
This study assesses the safety and effectiveness of oral Gabapentin compared to Diclofenac Potassium for managing postoperative pain in patients who have undergone surface ablation. It aims to determine if Gabapentin provides superior analgesic effects and reduces pain severity after photorefractive keratectomy. The study will involve measuring pain levels using a Visual Analog Scale (VAS) in participants receiving either medication post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with stable preoperative refraction and normal corneal tomography.
Not a fit: Patients with significant ocular conditions, a history of previous ocular surgeries, or those over 65 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a more effective pain management option for patients recovering from eye surgery.
How similar studies have performed: While there have been studies on postoperative pain management, the specific comparison of Gabapentin to Diclofenac Potassium in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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, * 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
Where this trial is running
Giza
- Research Institute of Ophthalmolgy — Giza, Egypt (Recruiting)
Study contacts
- Study coordinator: Dina Moustafa M Ali, MD
- Email: dina.moustafa.ali@gmail.com
- Phone: 01113981021
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.