Fasudil Eye Drop in Retinopathy Of Prematurity(ROP)
- Conditions
- Retinopathy of Prematurity
- Interventions
- Drug: receive artificial tears drop
- Registration Number
- NCT04191954
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Eligible eyes are randomly assigned into two groups. Group A receive Fasudil eye drops (concentration 0.5 percent) twice daily. Group B, receive artificial tears drop with the same frequency. Retinal specialists who are expert in Retinopathy Of Prematurity field will perform fundus examination regularly. The examiners are blind. The progression of normal retinal vascularization and need to treatment will be documented and compared between the two study groups. The topical eye drops are used until the retinal vascularization are complete (45 week after LMP) or the patient needs to be treated.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 184
- Premature infants who are candidate for retinopathy of prematurity (ROP) screening with ROP Type 2
- Serious systemic problems
- Other ocular problems Except ROP
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fasudil eye drops (concentration 0.5 percent) Fasudil eye drops (concentration 0.5 percent) twice daily receive artificial tears drop with the same frequency receive artificial tears drop -
- Primary Outcome Measures
Name Time Method Stimulation of normal retinal vascularization and disease progression inhibition 3 months Fundoscopy and examiner judgment which will be documented by retinal camera
- Secondary Outcome Measures
Name Time Method Any adverse event 3 months Neonatologist and ophthalmologist examination
Trial Locations
- Locations (1)
Ophthalmic Research Center
🇮🇷Tehran, Iran, Islamic Republic of