Clinical trial NCT05338411: Effect of Exogenous Growth Hormone on Ocular Findings
Official title: Effect of Exogenous Growth Hormone on Ocular Findings of Children With Precocious and Early Puberty: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Precocious Puberty
Early Puberty
Refraction Error
Keywords: Precocious Puberty
Early Puberty
human growth hormone
Refraction Error
Axial Length
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 90
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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:

1. Demographics
2. Past medical history

3. Bone and calendar age

4- Stage of puberty

5- Ocular examination

6. Ocular biometry

Eligibility criteria: 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

Primary outcomes:
measure: Refraction Error
timeFrame: 6 months
measure: Axial Length
timeFrame: 6 months
Secondary outcomes:
measure: Papillitis
timeFrame: 6 months
measure: Central Corneal Thickness
timeFrame: 6 months
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Isfahan University of Medical Sciences
city: Isfahan
country: Iran, Islamic Republic of
facility: Isfahan Eye Research Center
Study officials:
References: