Retinopathy of Prematurity
Conditions
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.
Interventions
DRUGFasudil eye drops (concentration 0.5 percent)
receive Fasudil eye drops (concentration 0.5 percent) twice daily
DRUGreceive artificial tears drop
receive artificial tears drop with the same frequency
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
No minimum to 45 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Premature infants who are candidate for retinopathy of prematurity (ROP) screening with ROP Type 2
Exclusion criteria
* Serious systemic problems * Other ocular problems Except ROP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stimulation of normal retinal vascularization and disease progression inhibition | 3 months | Fundoscopy and examiner judgment which will be documented by retinal camera |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Any adverse event | 3 months | Neonatologist and ophthalmologist examination |
Countries
Iran
Contacts
Primary ContactAlireza Ramezani, MD
Outcome results
None listed