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

Sponsor

Rabin Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04593745

Collaborator

(none)

100

Enrollment

Location

Arm

71.8

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
ALL, Childhood Steroid-Induced Glaucoma	Device: Intraocular pressure measurment	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Intraocular Pressure in Children With ALL Treated With High Dose Steroids

Actual Study Start Date :

Jul 9, 2018

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

intra-ocular pressure (IOP) [15 days of steroid treatment]
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) [1 month of steroid treatment]
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.)

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Schneider Children's Medical Center of Israel	Petach Tikva		Israel

Sponsors and Collaborators

Rabin Medical Center

Investigators

Principal Investigator: Shlomi Barzilai Birenboim, Schneider Children's Medical Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rabin Medical Center

ClinicalTrials.gov Identifier:

NCT04593745

Other Study ID Numbers:

0262-18-RMC

First Posted:

Oct 20, 2020

Last Update Posted:

Oct 22, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Study Results

No Results Posted as of Oct 22, 2021