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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intraocular Pressure in Children With ALL Treated With High Dose Steroids

Conditions
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ALL, Childhood, Steroid-Induced Glaucoma

Intervention / Treatment
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* Device: Intraocular pressure measurment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ALL AIEOP-BFM induction<br>Intraocular pressure messured in children treated with steroids | Device: Intraocular pressure measurment<br>* Intraocular pressure measurmentt using iCare devise: TONOPEN<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intra-ocular pressure (IOP) | Elevated IOP will be defined as pressure >21 mmHg; The risk of developing elevated IOP will be correlated with potential risk factors (T ALL vs. B ALL; WBC at diagnosis; initial IOP at diagnosis etc.) | 15 days of steroid treatment | 
| intra-ocular pressure (IOP) | Elevated IOP will be defined as pressure >21 mmHg; The risk of developing elevated IOP will be correlated with potential risk factors (T ALL vs. B ALL; WBC at diagnosis; initial IOP at diagnosis etc.) | 1 month of steroid treatment |