About this trial
Purpose:
To evaluate the incidence and severity of hypoxia and address a genuine evidence gap focusing on intraprocedural hypoxia during bedside intravitreal ranibizumab injection for retinopathy of prematurity (ROP), an area that has been only sparsely investigated in premature infants treated across multiple hospitals in the Al Qassim region of Saudi Arabia
Methods:
A retrospective multicenter observational study was conducted at Ophthalmology Department, Qassim University Medical City involving premature infants who underwent intravitreal Ranibizumab injection for treatment-requiring ROP between July 2020 and June 2026. Demographic, maternal, perinatal, ophthalmic, and treatment-related data were collected registered and analyzed. Continuous pulse oximetry monitoring was recorded during bedside neonatal intensive care unit (NICU) procedures. Hypoxia was classified as mild (oxygen saturation 85-89%), moderate (80-84%), or severe (\<80%).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Premature infants with treatment-requiring ROP.
Treatment with intravitreal ranibizumab.
Complete procedural monitoring records, including continuous pulse oximetry.
Availability of follow-up data after treatment.
Disqualifiers
Incomplete procedural or follow-up data.
Major congenital anomalies affecting cardiorespiratory function.
Bronchopulmonary dysplasia.
Intraventricular hemorrhage.
Trial population
A retrospective multicenter observational study was conducted at Ophthalmology Department, Qassim University Medical City involving premature infants who underwent intravitreal Ranibizumab injection for treatment-requiring ROP between July 2020 and June 2026. Demographic, maternal, perinatal, ophthalmic, and treatment-related data were collected registered and analyzed.
Trial design
Cohort
Retrospective
Treatments tested in this trial
ranibizumab
DrugIntra-vitrail injection
Treatment groups
Trial outcomes
Primary outcomes
Hyopxia
Incidence of hypoxia during intravitreal anti-VEGF
Sponsors and contacts
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