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

Intraocular Pressure in Children With ALL Treated With High Dose Steroids

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.

Study Overview

• Status: Recruiting
• Conditions: ALL, Childhood; Steroid-Induced Glaucoma
• Intervention / Treatment: Device: Intraocular pressure measurment

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shlomit Barzilai Birenboim, MD; Phone Number: 03-9253461; Email: Bshlomit@clalit.org.il

Study Locations

• Israel
  • Petach Tikva, Israel
    • Recruiting
    • Schneider Children's Medical Center of Israel
    • Contact: Naomi Litichever, PhD; Phone Number: 972-3-9253669

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 20 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: ALL AIEOP-BFM induction; Intraocular pressure messured in children treated with steroids	Device: Intraocular pressure measurment; Intraocular pressure measurmentt using iCare devise: TONOPEN

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Shlomi Barzilai Birenboim, Schneider Children's Medical Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 9, 2018
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): July 1, 2024

Study Registration Dates

• First Submitted: April 5, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (ACTUAL): October 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia, Lymphoid; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: 0262-18-RMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: upon request

Drug and device information, study documents

• 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