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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALL AIEOP-BFM induction | Other | Intraocular pressure messured in children treated with steroids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraocular pressure measurment | Device | Intraocular pressure measurmentt using iCare devise: TONOPEN |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
* Any prior eye condition that can affect intra ocular pressure or its measurement
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shlomit Barzilai Birenboim, MD | Contact | 03-9253461 | Bshlomit@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Shlomi Barzilai Birenboim | Schneider Children's Medical Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schneider Children's Medical Center of Israel | Recruiting | Petah Tikva | Israel |
upon request
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |