Bromfenac eye drops for treating a specific eye condition
Efficacy of Bromfenac Sodium Hydrate Eye Drops in Children With Familial Exudative Vitreoretinopathy After Diode Laser Photocoagulation
PHASE2 · Seoul National University Hospital · NCT05107921
This study tests if bromfenac eye drops can help people with familial exudative vitreoretinopathy who are getting laser treatment by reducing swelling in the eye.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 39 (estimated) |
| Ages | 1 Month to 7 Years |
| Sex | All |
| Sponsor | Seoul National University Hospital (other) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05107921 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of bromfenac sodium hydrate eye drops in patients diagnosed with familial exudative vitreoretinopathy who are also receiving diode laser photocoagulation. The primary focus is on evaluating the presence of macular edema, while conjunctival injection serves as a secondary measure. The study aims to provide insights into how bromfenac can improve treatment outcomes for this condition.
Who should consider this trial
Good fit: Ideal candidates are newly diagnosed patients with familial exudative vitreoretinopathy who require diode laser photocoagulation.
Not a fit: Patients with a history of corneal diseases, hypersensitivity to bromfenac sodium, or those on anticoagulation drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve visual outcomes for patients with familial exudative vitreoretinopathy.
How similar studies have performed: While this approach is novel for this specific condition, similar studies with bromfenac in other ocular conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newly diagnosed patients with familial exudative vitreoretinopathy * Needing diode laser photocoagulation * Consent to the study Exclusion Criteria: * History of corneal diseases * History of hypersensitivity to bromfenac sodium * History of hypersensitivity to non-steroidal anti-inflammatory drugs * Progressive ocular infection * Liver diseases * Hypersensitivity to sulfur dioxide * Receiving anti-coagulation drugs * History of coagulopathies
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, Korea, Republic of (RECRUITING)
Study contacts
- Principal investigator: Jeong Hun Kim, MD, PhD — Seoul National University Hospital
- Study coordinator: Jeong Hun Kim, MD, PhD
- Email: steph25@snu.ac.kr
- Phone: 82-2-2072-3446
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.
Conditions: Familial Exudative Vitreoretinopathies