Effect of Exogenous Growth Hormone on Ocular Findings

NCT05338411 | Unknown

• 1 other identifier: IR.ARI.MUI.REC.1400.121
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Precocious Puberty; Early Puberty; Refraction Error

Keywords

Precocious Puberty; Early Puberty; human growth hormone; Refraction Error; Axial Length

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Papillitis

  6 months

• Central Corneal Thickness

  6 months

Study Arms (3)

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

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Sample group (with early or precocious puberty):
• Children with precocious puberty based on Tanner classification
• Girls 4 to 10 years old
• Boys aged 4 to 11
• No known eye problems including: history of eye trauma, eye surgery 5- lack of family history of glaucoma or increased intraocular pressure
• \. Lack of previous history of receiving growth hormone 7. Lack of systemic disease or known syndromes 8. Consent to participate in the study

You may not qualify if:

• Incidence of growth hormone adverse reactions leading to discontinuation of treatment
• Changing the patient's treatment plan during the study
• Ocular complications requiring treatment during the study
• Unwillingness of the patient to continue participating in the study

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (2)

Isfahan University of Medical Sciences

Isfahan, +98, Iran

RECRUITING

Isfahan Eye Research Center

Isfahan, 81746-73461, Iran

RECRUITING

MeSH Terms

Conditions

Puberty, Precocious; Refractive Errors

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Eye Diseases

Central Study Contacts

Mohsen Pourazizi, MD

CONTACT

00983134452036; m.pourazizi@med.mui.ac.ir

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Mohsen Pourazizi

Study Record Dates

• First Submitted: April 10, 2022
• First Posted: April 21, 2022
• Study Start: March 20, 2022
• Primary Completion: October 22, 2023
• Study Completion: October 22, 2023
• Last Updated: April 21, 2022

Record last verified: 2022-04

Locations

IR (2)