Incidence of Hypoxia During Intravitreal Anti-VEGF (Vascular Endothelial Growth Factor) Injection… (NCT07701759) | Clinical Trial Compass
RecruitingNot Applicable
Incidence of Hypoxia During Intravitreal Anti-VEGF (Vascular Endothelial Growth Factor) Injections for Retinopathy of Prematurity (ROP) Under Topical Anesthesia
Saudi Arabia74 participantsStarted 2025-10-01
Plain-language summary
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%).
Who can participate
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
* 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.
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1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
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Questions for the trial coordinator
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1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
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6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.