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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasudil eye drops (concentration 0.5 percent) | Active Comparator | twice daily |
|
| receive artificial tears drop with the same frequency | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasudil eye drops (concentration 0.5 percent) | Drug | receive Fasudil eye drops (concentration 0.5 percent) twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stimulation of normal retinal vascularization and disease progression inhibition | Fundoscopy and examiner judgment which will be documented by retinal camera | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Any adverse event | Neonatologist and ophthalmologist examination | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alireza Ramezani, MD | Contact | 009822591616 | labbafi@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmic Research Center | Recruiting | Tehran | Iran |
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| ID | Term |
|---|---|
| D012178 | Retinopathy of Prematurity |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D007235 | Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
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| receive artificial tears drop | Drug | receive artificial tears drop with the same frequency |
|
| D009358 |
| Congenital, Hereditary, and Neonatal Diseases and Abnormalities |