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

Clalit Health Services

Status: Enrolling

Conditions: ALL, Childhood; Steroid-Induced Glaucoma

Treatments: Device: Intraocular pressure measurment

Study type: Interventional

Funder types: Other

Identifiers

NCT04593745

0262-18-RMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 1 month to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ALL diagnosis
• treated with an AIEOP-BFM protocol (including steroids)

Exclusion criteria

* Any prior eye condition that can affect intra ocular pressure or its measurement

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

ALL AIEOP-BFM induction

Other group

Description:

Intraocular pressure messured in children treated with steroids

Treatment:

Device: Intraocular pressure measurment