Is Recombinant Growth Hormone Therapy Associated With Increased Intraoccular Pressure?

Glaucoma Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00867971
• Other study ID #: 162/08
• Status: Active, not recruiting
• Phase: N/A
• First received: March 22, 2009
• Last updated: March 22, 2009
• Start date: February 2009
• Est. completion date: October 2010

Study information

• Verified date: February 2009
• Source: Assaf-Harofeh Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Glaucoma
• Growth Hormone Treatment

Intervention

Other:
• Measuring intraoccular pressure
Measurement of intraoccular pressure by tonometry

Locations

Country	Name	City	State
Israel	Assaf harofeh medical center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoccular pressure in children treated with RGH		2 years	Yes