Is Recombinant Growth Hormone Therapy Associated With Increased Intraoccular Pressure?

March 22, 2009 updated by: Assaf-Harofeh Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Zerifin, Israel
        • Assaf Harofeh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children age 6-18 treated with growth hormone

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RGH treated
Other: Measuring intraoccular pressure
Measurement of intraoccular pressure by tonometry
Starting treatment with RGH
Other: Measuring intraoccular pressure
Measurement of intraoccular pressure by tonometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraoccular pressure in children treated with RGH
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assaf-Harofeh Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Anticipated)

October 1, 2010

Study Completion (Anticipated)

October 1, 2010

Study Registration Dates

First Submitted

March 22, 2009

First Submitted That Met QC Criteria

March 22, 2009

First Posted (Estimate)

March 24, 2009

Study Record Updates

Last Update Posted (Estimate)

March 24, 2009

Last Update Submitted That Met QC Criteria

March 22, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 162/08

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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