Effect of Exogenous Growth Hormone on Ocular Findings

Precocious Puberty Clinical Trial

Official title:

Effect of Exogenous Growth Hormone on Ocular Findings of Children With Precocious and Early Puberty: a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05338411
• Other study ID #: IR.ARI.MUI.REC.1400.121
• Status: Recruiting
• Start date: March 20, 2022
• Est. completion date: October 22, 2023

Study information

• Verified date: April 2022
• Source: Isfahan University of Medical Sciences
• Contact: Mohsen Pourazizi, MD
• Phone: 00983134452036
• Email: m.pourazizi[@]med.mui.ac.ir
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Body size and eye function play an essential role in adapting to the environment and human survival. Growth hormone is commonly recognized by its effect on the height of individuals; Although from an evolutionary perspective, the effects of growth hormone on eye development are more important. Although the effect of growth hormone on eye development has not been accurately determined, the results of a number of studies suggest the effect of growth hormone on eye development. Despite the large number of studies that have investigated the effects of growth hormone on height growth, there are few studies that have investigated the effects of growth hormone on the eye. To the best of our knowledge, no study has been conducted to investigate the effect of growth hormone on ocular findings of patients with early or precocious puberty. Therefore, we intend to investigate the effect of growth hormone on ocular findings of patients with early or precocious puberty.

Description:

Investigators will achieve the following data from the participants: 1. Demographics 2. Past medical history 3. Bone and calendar age 4- Stage of puberty 5- Ocular examination 6. Ocular biometry

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 22, 2023
• Est. primary completion date: October 22, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 11 Years

Eligibility

Inclusion Criteria:

Sample group (with early or precocious puberty):

1. Children with precocious puberty based on Tanner classification

2. Girls 4 to 10 years old

3. Boys aged 4 to 11

4. No known eye problems including: history of eye trauma, eye surgery 5- lack of family history of glaucoma or increased intraocular pressure

6. Lack of previous history of receiving growth hormone 7. Lack of systemic disease or known syndromes 8. Consent to participate in the study

Exclusion Criteria:

1. Incidence of growth hormone adverse reactions leading to discontinuation of treatment

2. Changing the patient's treatment plan during the study

3. Ocular complications requiring treatment during the study

4. Unwillingness of the patient to continue participating in the study

Related Conditions & MeSH terms

• Early Puberty
• Precocious Puberty
• Puberty, Precocious
• Refraction Error
• Refractive Errors

Locations

Country	Name	City	State
Iran, Islamic Republic of	Isfahan Eye Research Center	Isfahan
Iran, Islamic Republic of	Isfahan University of Medical Sciences	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Refraction Error	Comparison of the refraction error between the study groups	6 months
Primary	Axial Length	Comparison of the axial length between the study groups	6 months
Secondary	Papillitis	Comparison of the frequency of papillitis between the study groups	6 months
Secondary	Central Corneal Thickness	Comparison of the mean central corneal thickness between the study groups	6 months