Effect of Exogenous Growth Hormone on Ocular Findings

Study Overview
=================
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.

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

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

Conditions
-----------------
Precocious Puberty, Early Puberty, Refraction Error

Participation Criteria
=================
Eligibility Criteria
-----------------
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 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: 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

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 11 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early or precocious puberty who receive GH<br>Children with early or precocious puberty who receive exogenous growth hormone | |
| Early or precocious puberty who does not receive GH<br>Children with early or precocious puberty who does not receive exogenous growth hormone | |
| Healthy<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Precocious Puberty, Early Puberty, human growth hormone, Refraction Error, Axial Length