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

  • STATUS
    Recruiting
  • End date
    Jul 27, 2024
  • participants needed
    100
  • sponsor
    Rabin Medical Center
Updated on 27 October 2021

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.

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.

Details
Condition childhood ALL, Steroid-Induced Glaucoma, Lymphocytic Leukemia, Acute
Treatment Intraocular pressure measurment
Clinical Study IdentifierNCT04593745
SponsorRabin Medical Center
Last Modified on27 October 2021

Eligibility

Yes No Not Sure

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
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