Bromfenac Sodium Hydrate Eye Drops in Familial Exudative Vitreoretinopathy
Phase 2
Recruiting
- Conditions
- Familial Exudative Vitreoretinopathies
- Interventions
- Registration Number
- NCT05107921
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
This study aims to investigate the efficacy and safety of bromfenac sodium hydrate eye drops in patients with familial exudative vitreoretinopathy receiving diode laser photocoagulation.
- Detailed Description
This study aims to evaluate the presence of macular edema as the primary measure and the presence of conjunctival injection as the secondary measure for the investigation of the efficacy of bromfenac sodium hydrate eye drops in patients with familial exudative vitreoretinopathy receiving diode laser photocoagulation.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 39
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bromfenac sodium hydrate eye drops Bromfenac Sodium The patients will receive bromfenac sodium hydrate eye drops twice daily for 14 days.
- Primary Outcome Measures
Name Time Method Macular edema response rate 4 weeks after the diode laser photocoagulation Presence of macular edema
- Secondary Outcome Measures
Name Time Method Conjunctival injection response rate 4 weeks after the diode laser photocoagulation Presence of conjunctival injection
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of