Intraocular Pressure in Children With Acute Lymphoblastic Leukemia (ALL) Treated With High Dose Steroids
ALL
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 9, 2018
CompletedFirst Submitted
Initial submission to the registry
April 5, 2020
CompletedFirst Posted
Study publicly available on registry
October 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedOctober 22, 2021
October 1, 2021
4.9 years
April 5, 2020
October 21, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
ALL AIEOP-BFM induction
OTHERIntraocular pressure messured in children treated with steroids
Interventions
Intraocular pressure measurmentt using iCare devise: TONOPEN
Eligibility Criteria
You may qualify if:
- ALL diagnosis
- treated with an AIEOP-BFM protocol (including steroids)
You may not qualify if:
- \* Any prior eye condition that can affect intra ocular pressure or its measurement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Schneider Children's Medical Center of Israel
Petah Tikva, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shlomi Barzilai Birenboim
Schneider Children's Medical Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2020
First Posted
October 20, 2020
Study Start
July 9, 2018
Primary Completion
June 1, 2023
Study Completion
July 1, 2024
Last Updated
October 22, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share
upon request