Retinopathy of Prematurity. Retinopathy of prematurity
Conditions
Interventions
Intervention 1: Control group: One eye of each participant will be randomly assigned to the control group. The control group will undergo routine pan-avascular laser therapy. In this method, laser the
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Infants with type 1 prethreshold ROP ( stage 2 or 3 with plus disease ) in both eyes in zone ll Gestational age between 26-32 weeks or birth weight 32 weeks and unstable clinical course
Exclusion criteria
Exclusion criteria: Infants with contraindications for lasertherapy Infants with ROP in zone l or lll or posterior of zone ll Infants with unilateral ROP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrence of ROP in treated infants. Timepoint: fundoscopic examination before intervention and weekly examination after laser treatment until Gestational age of 50-60 weeks. Method of measurement: Clinical examination with an indirect ophthalmoscope by a retinal specialist and retinal imaging using a RETCAM device. | — |
Secondary
| Measure | Time frame |
|---|---|
| Refractive error after laser treatment. Timepoint: Measurement of refractive error at 50-60 weeks of gestation. Method of measurement: Retinoscopy by an experienced optometrist and reporting it as refraction in Diopters.;Treatment related complications (Undertreatment, Retinal burn,Retinal breaks , Choroidal bleeding, Iris burn, Anterior segment hemorrhage, Inflammation, Anterior segment ischemia, Cataract and Myopia). Timepoint: Occurrence of complications until gestational age of 50-60 weeks. Method of measurement: Clinical examination with indirect ophthalmoscope by a retinal specialist and report of the mentioned complications, if any. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactEhsan Yazdani
Shahid Beheshti University of Medical Sciences
Outcome results
None listed