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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMinia University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • ranibizumab

    Drug

    Intra-vitrail injection

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Hyopxia

Incidence of hypoxia during intravitreal anti-VEGF

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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