Incidence of Hypoxia During Intravitreal Anti-VEGF (Vascular Endothelial Growth Factor) Injections for Retinopathy of Prematurity (ROP) Under Topical Anesthesia

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%).

NCT Number	NCT07701759
Lead Sponsor	Minia University
Conditions	Retinopathy of Prematurity
Enrollment	74 participants
Start Date	2025-10-01
Primary Completion	2026-07-15 (estimated)
Study Completion	2026-10-01 (estimated)
Updated on ClinicalTrials.gov	2026-07-14