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

ALL, Childhood Clinical Trial

— ALL  

Official title:

Intraocular Pressure in Children With ALL Treated With High Dose Steroids

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04593745
• Other study ID #: 0262-18-RMC
• Status: Recruiting
• Phase: N/A
• Start date: July 9, 2018
• Est. completion date: July 2024

Study information

• Verified date: October 2021
• Source: Rabin Medical Center
• Contact: Shlomit Barzilai Birenboim, MD
• Phone: 03-9253461
• Email: Bshlomit[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 2024
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• ALL, Childhood
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Steroid-Induced Glaucoma

Intervention

Device:
• Intraocular pressure measurment
Intraocular pressure measurmentt using iCare devise: TONOPEN

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center of Israel	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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