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Status unknownNCT05338411Updated Apr 21, 2022

Effect of Exogenous Growth Hormone on Ocular Findings

An observational study in Precocious Puberty, Early Puberty and Refraction Error, sponsored by Isfahan University of Medical Sciences. Status unknown at 2 sites in Iran, Islamic Republic of. Open to participants aged 4 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-21.

Sponsored by Isfahan University of Medical Sciences · Observational

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
90
Ages
4 Years to 11 Years
Sex
All
01

Study 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.

Read the detailed description

Investigators will achieve the following data from the participants:

  1. Demographics
  2. Past medical history
  1. Bone and calendar age

4- Stage of puberty

5- Ocular examination

  1. Ocular biometry
02

Conditions studied

  • Precocious Puberty
  • Early Puberty
  • Refraction Error

Keywords

  • Precocious Puberty
  • Early Puberty
  • human growth hormone
  • Refraction Error
  • Axial Length
03

In context

Refractive Errors

413 studies on the registry are indexed under Refractive Errors; 62 are open to participants now.

This study's planned enrollment of 90 is below the median of 150 across 107 observational studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

Isfahan University of Medical Sciences is the lead sponsor of 145 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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
  1. 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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No

Groups and cohorts

  • Early or precocious puberty who receive GH

    Children with early or precocious puberty who receive exogenous growth hormone

  • Early or precocious puberty who does not receive GH

    Children with early or precocious puberty who does not receive exogenous growth hormone

  • Healthy

    Healthy children without any past medical history

06

What researchers measure

Primary outcomes

  1. Refraction Error

    Comparison of the refraction error between the study groups

    Time frame: 6 months

  2. Axial Length

    Comparison of the axial length between the study groups

    Time frame: 6 months

Secondary outcomes

  1. Papillitis

    Comparison of the frequency of papillitis between the study groups

    Time frame: 6 months

  2. Central Corneal Thickness

    Comparison of the mean central corneal thickness between the study groups

    Time frame: 6 months

07

Study locations

2 of 2 sites recruiting
  • Isfahan University of Medical Sciences
    Isfahan, +98, Iran, Islamic Republic of
    Recruiting
  • Isfahan Eye Research Center
    Isfahan, 81746-73461, Iran, Islamic Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05338411
Lead sponsor
Isfahan University of Medical Sciences
Responsible party
Mohsen Pourazizi (Dr. Mohsen Pourazizi, Isfahan University of Medical Sciences) — Principal investigator
First posted
Apr 21, 2022
Start date
Mar 20, 2022
Primary completion
Oct 22, 2023 (estimated)
Completion
Oct 22, 2023 (estimated)
Last update
Apr 21, 2022

Study contacts

Mohsen Pourazizi, MD
Contact
m.pourazizi@med.mui.ac.ir
00983134452036

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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