Effect of Exogenous Growth Hormone on Ocular Findings

NCT ID: NCT05338411

Last Updated: 2022-04-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-20

Study Completion Date

2023-10-22

Brief Summary

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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

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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

Conditions

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Precocious Puberty Early Puberty Refraction Error

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Early or precocious puberty who receive GH

Children with early or precocious puberty who receive exogenous growth hormone

No interventions assigned to this group

Early or precocious puberty who does not receive GH

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

No interventions assigned to this group

Healthy

Healthy children without any past medical history

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Mohsen Pourazizi

Dr. Mohsen Pourazizi

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Isfahan University of Medical Sciences

Isfahan, , Iran

Site Status RECRUITING

Isfahan Eye Research Center

Isfahan, , Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Mohsen Pourazizi, MD

Role: CONTACT

00983134452036

Facility Contacts

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Mohsen Pourazizi

Role: primary

+983134452031

Mohsen Pourazizi, M.D.

Role: primary

00983134452036

Other Identifiers

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IR.ARI.MUI.REC.1400.121

Identifier Type: -

Identifier Source: org_study_id

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