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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05338411
Other study ID # IR.ARI.MUI.REC.1400.121
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 20, 2022
Est. completion date October 22, 2023

Study information

Verified date April 2022
Source Isfahan University of Medical Sciences
Contact Mohsen Pourazizi, MD
Phone 00983134452036
Email m.pourazizi@med.mui.ac.ir
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

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

Study Design


Locations

Country Name City State
Iran, Islamic Republic of Isfahan Eye Research Center Isfahan
Iran, Islamic Republic of Isfahan University of Medical Sciences Isfahan

Sponsors (1)

Lead Sponsor Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

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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