Intraocular Pressure in Children With Acute Lymphoblastic Leukemia (ALL) Treated With High Dose Steroids
NCT ID: NCT04593745
Last Updated: 2021-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2018-07-09
2024-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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ALL AIEOP-BFM induction
Intraocular pressure messured in children treated with steroids
Intraocular pressure measurment
Intraocular pressure measurmentt using iCare devise: TONOPEN
Interventions
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Intraocular pressure measurment
Intraocular pressure measurmentt using iCare devise: TONOPEN
Eligibility Criteria
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Inclusion Criteria
* treated with an AIEOP-BFM protocol (including steroids)
Exclusion Criteria
1 Month
20 Years
ALL
No
Sponsors
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Rabin Medical Center
OTHER
Responsible Party
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Principal Investigators
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Shlomi Barzilai Birenboim
Role: PRINCIPAL_INVESTIGATOR
Schneider Children's Medical Hospital
Locations
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Schneider Children's Medical Center of Israel
Petah Tikva, , Israel
Countries
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Central Contacts
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Facility Contacts
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Naomi Litichever, PhD
Role: primary
Other Identifiers
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0262-18-RMC
Identifier Type: -
Identifier Source: org_study_id