Is Recombinant Growth Hormone Therapy Associated With Increased Intraoccular Pressure?

NCT ID: NCT00867971

Last Updated: 2009-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Recombinant growth hormone is a common therapy in the pediatric population. A number of associated side effects have been described. Several years ago, a case report was published concerning a child that was treated with RGH and developed acute glaucoma. To date no study has evaluated the connection.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Growth Hormone Treatment Glaucoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

RGH treated

Measuring intraoccular pressure

Intervention Type OTHER

Measurement of intraoccular pressure by tonometry

Starting treatment with RGH

Measuring intraoccular pressure

Intervention Type OTHER

Measurement of intraoccular pressure by tonometry

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Measuring intraoccular pressure

Measurement of intraoccular pressure by tonometry

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 6-18 years
* treatment with recombinant growth hormone

Exclusion Criteria

* Underlying Chronic diseases
* Family history of eye diseases
* elevated occular pressure prior to starting treatment
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Assaf Harofeh Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assaf harofeh medical center

Ẕerifin, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

References

Explore related publications, articles, or registry entries linked to this study.

Youngster I, Rachmiel R, Pinhas-Hamiel O, Bistritzer T, Zuckerman-Levin N, de Vries L, Naugolny L, Eyal O, Braunstein R, Rachmiel M. Treatment with recombinant human growth hormone during childhood is associated with increased intraocular pressure. J Pediatr. 2012 Dec;161(6):1116-9. doi: 10.1016/j.jpeds.2012.05.024. Epub 2012 Jun 23.

Reference Type DERIVED
PMID: 22727870 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

162/08

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.