Incidence of Hypoxia During Intravitreal Anti-VEGF (Vascular Endothelial Growth Factor) Injections for Retinopathy of Prematurity (ROP) Under Topical Anesthesia
Recruiting now
Conditions studied: Retinopathy of Prematurity
In brief
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%).
Key facts
- Study ID
- NCT07701759
- Run by
- Minia University
- People needed
- 74
- Starts
- 2025-10-01
- Expected to finish
- 2026-10-01
- Last updated by the study team
- 2026-07-14
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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. Exclusion criteria
- Infants were excluded if they had:
- Incomplete procedural or follow-up data.
- Major congenital anomalies affecting cardiorespiratory function.
- Bronchopulmonary dysplasia.
- Intraventricular hemorrhage.
- Patent ductus arteriosus.
- Respiratory distress syndrome requiring surfactant therapy.
Where it is running
- QUMC — Buraidah, Saudi Arabia (enrolling)
Full record on ClinicalTrials.gov
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