Back to resultsIntraocular Pressure in Children With Acute Lymphoblastic Leukemia (ALL) Treated With High Dose Steroids (ALL)
Primary Purpose
ALL, Childhood, Steroid-Induced Glaucoma
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Intraocular pressure measurment
Sponsored by
About this trial
This is an interventional prevention trial for ALL, Childhood
Eligibility Criteria
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
Sites / Locations
- Schneider Children's Medical Center of IsraelRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ALL AIEOP-BFM induction
Arm Description
Intraocular pressure messured in children treated with steroids
Outcomes
Primary Outcome Measures
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.)
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.)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04593745
Brief Title
Intraocular Pressure in Children With Acute Lymphoblastic Leukemia (ALL) Treated With High Dose Steroids
Acronym
ALL
Official Title
Intraocular Pressure in Children With ALL Treated With High Dose Steroids
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 9, 2018 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ALL, Childhood, Steroid-Induced Glaucoma
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ALL AIEOP-BFM induction
Arm Type
Other
Arm Description
Intraocular pressure messured in children treated with steroids
Intervention Type
Device
Intervention Name(s)
Intraocular pressure measurment
Intervention Description
Intraocular pressure measurmentt using iCare devise: TONOPEN
Primary Outcome Measure Information:
Title
intra-ocular pressure (IOP)
Description
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.)
Time Frame
15 days of steroid treatment
Title
intra-ocular pressure (IOP)
Description
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.)
Time Frame
1 month of steroid treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shlomit Barzilai Birenboim, MD
Phone
03-9253461
Email
Bshlomit@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shlomi Barzilai Birenboim
Organizational Affiliation
Schneider Children's Medical Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schneider Children's Medical Center of Israel
City
Petach Tikva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naomi Litichever, PhD
Phone
972-3-9253669
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
upon request
Learn more about this trial
Intraocular Pressure in Children With Acute Lymphoblastic Leukemia (ALL) Treated With High Dose Steroids
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