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

Not Applicable

• Conditions: Steroid-Induced Glaucoma; ALL, Childhood
• Interventions: Device: Intraocular pressure measurment

• Registration Number: NCT04593745
• Lead Sponsor: Rabin Medical Center

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.

Study Timeline

• Study Start: 2018-07-09
• Study First Submitted: 2020-04-05
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-20
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-21
• Last Update Posted: 2021-10-22
• Primary Completion: 2023-06
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALL AIEOP-BFM induction	Intraocular pressure measurment	Intraocular pressure messured in children treated with steroids

Primary Outcome Measures

Name	Time	Method
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.)

Trial Locations

Locations (1)

Schneider Children's Medical Center of Israel; 🇮🇱 Petach Tikva, Israel