Effect of Exogenous Growth Hormone on Ocular Findings

Sponsor

Isfahan University of Medical Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT05338411

Collaborator

(none)

Enrollment

Locations

19.1

Anticipated Duration (Months)

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Precocious Puberty Early Puberty Refraction Error

Detailed Description

Investigators will achieve the following data from the participants:

Demographics
Past medical history
Bone and calendar age

4- Stage of puberty

5- Ocular examination

Ocular biometry

Study Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 20, 2022

Anticipated Primary Completion Date :

Oct 22, 2023

Anticipated Study Completion Date :

Oct 22, 2023

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

Refraction Error [6 months]
Comparison of the refraction error between the study groups
Axial Length [6 months]
Comparison of the axial length between the study groups

Secondary Outcome Measures

Papillitis [6 months]
Comparison of the frequency of papillitis between the study groups
Central Corneal Thickness [6 months]
Comparison of the mean central corneal thickness between the study groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 11 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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