Effect of Exogenous Growth Hormone on Ocular Findings

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

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.

Study Overview

• Status: Recruiting
• Conditions: Precocious Puberty; Refraction Error; Early Puberty

Detailed 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

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

• Study Contact: Name: Mohsen Pourazizi, MD; Phone Number: 00983134452036; Email: m.pourazizi@med.mui.ac.ir

Study Locations

• Iran, Islamic Republic of
  • Isfahan, Iran, Islamic Republic of, +98
    • Recruiting
    • Isfahan University of Medical Sciences
    • Contact: Mohsen Pourazizi; Phone Number: +983134452031; Email: m.pourazizi@yahoo.com
  • Isfahan, Iran, Islamic Republic of, 81746-73461
    • Recruiting
    • Isfahan Eye Research Center
    • Contact: Mohsen Pourazizi, M.D.; Phone Number: 00983134452036; Email: m.pourazizi@med.mui.ac.ir

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study groups are children with early or precocious puberty referred to endocrine clinic of Imam Hossein Hospital in Isfahan, Iran. The control group will be selected from the children who visit at the health centers for routine examinations.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Early or precocious puberty who receive GH; Children with early or precocious puberty who receive exogenous growth hormone
Early or precocious puberty who does not receive GH; Children with early or precocious puberty who does not receive exogenous growth hormone
Healthy; Healthy children without any past medical history

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Refraction Error	Comparison of the refraction error between the study groups	6 months
Axial Length	Comparison of the axial length between the study groups	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Papillitis	Comparison of the frequency of papillitis between the study groups	6 months
Central Corneal Thickness	Comparison of the mean central corneal thickness between the study groups	6 months

Collaborators and Investigators

• Sponsor: Isfahan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2022
• Primary Completion (Anticipated): October 22, 2023
• Study Completion (Anticipated): October 22, 2023

Study Registration Dates

• First Submitted: April 10, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 15, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Precocious Puberty; human growth hormone; Axial Length; Early Puberty; Refraction Error
• Additional Relevant MeSH Terms: Eye Diseases; Endocrine System Diseases; Gonadal Disorders; Refractive Errors; Puberty, Precocious
• Other Study ID Numbers: IR.ARI.MUI.REC.1400.121

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No