NCT04593745

Intraocular Pressure in Children With Acute Lymphoblastic Leukemia (ALL) Treated With High Dose Steroids

Intraocular Pressure in Children With ALL Treated With High Dose Steroids

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 1 Month – 20 Years
• Healthy volunteers: Not accepted

Summary

Childhood ALL patients are treated with high dose steroids. The study will follow the intraocular pressure of children treated in according to an AIEOP-BFM protocol, during the induction phase that will be compared to the pressure before treatment. Potential risk factors for developing elevated intraocular pressure will be estimated.

Detailed description

Children with ALL in Israel are treating according to the BFM ALL Protocol which contains high dose steroid therapy. One of the known side effects of high dose steroids is Intraocular hypertension, glaucoma, and even irreversible optic nerve injury. Early diagnosis of elevated intraocular pressure (IOP) and early therapeutic interventions might help to prevent future ocular damage. The purpose of this study is to determine the risk of developing evaluate Intraocular pressure during high dose steroid therapy. If elevated IOP will be common enough, we will try to corelate the risk of elevated IOP with potential risk factors, such as initial IOP, WBC at diagnosis, etc. Intraocular pressure will be measured by ophthalmologists using iCare devise: TONOPEN during general anesthesia at the day of diagnosis of ALL before steroid therapy initiation, and then after 15 and 33 days. Children with elevated IOP will continue ophthalmologists' follow up and treatment as necessary. All parents or patients' guardians will sign informed consent for participating in the study. The study group contains all newly diagnosed children with ALL in Schneider Children Medical Center.

Conditions

• ALL, Childhood
• Steroid-Induced Glaucoma

Interventions

Type	Name	Description
DEVICE	Intraocular pressure measurment	Intraocular pressure measurmentt using iCare devise: TONOPEN

Timeline

• Start date: 2018-07-09
• Primary completion: 2023-06-01
• Completion: 2024-07-01
• First posted: 2020-10-20
• Last updated: 2021-10-22

Locations

1 site across 1 country: Israel