Precocious Puberty Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | October 22, 2023 |
Est. primary completion date | October 22, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 11 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Isfahan Eye Research Center | Isfahan | |
Iran, Islamic Republic of | Isfahan University of Medical Sciences | Isfahan |
Lead Sponsor | Collaborator |
---|---|
Isfahan University of Medical Sciences |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Refraction Error | Comparison of the refraction error between the study groups | 6 months | |
Primary | Axial Length | Comparison of the axial length between the study groups | 6 months | |
Secondary | Papillitis | Comparison of the frequency of papillitis between the study groups | 6 months | |
Secondary | Central Corneal Thickness | Comparison of the mean central corneal thickness between the study groups | 6 months |
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