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临床试验/NCT05338411
NCT05338411Unknown不适用

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

Isfahan University of Medical Sciences2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年3月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
90
试验地点
2
主要终点
Refraction Error

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
4 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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
  • Lack of systemic disease or known syndromes
  • Consent to participate in the study

排除标准

  • 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

结局指标

主要结局

Refraction Error

时间窗: 6 months

Comparison of the refraction error between the study groups

Axial Length

时间窗: 6 months

Comparison of the axial length between the study groups

次要结局

  • Papillitis(6 months)
  • Central Corneal Thickness(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohsen Pourazizi

Dr. Mohsen Pourazizi

Isfahan University of Medical Sciences

研究点 (2)

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