Effect of Exogenous Growth Hormone on Ocular Findings | NCT05338411

Studies
Effect of Exogenous Growth Hormone on Ocular Findings

NCT05338411

Sponsor

Isfahan University of Medical Sciences

Status

Unknown status

Last Update Posted

Apr 21, 2022Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

Precocious Puberty
Early Puberty
Refraction Error

Interventions

Not provided

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2022Actual

Primary Completion Date

Oct 22, 2023Estimated

Completion Date

Oct 22, 2023Estimated

First Submitted Date

Apr 10, 2022

First Submission Date that Met QC Criteria

Apr 15, 2022

First Posted Date

Apr 21, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2022

Last Update Posted Date

Apr 21, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Investigators will achieve the following data from the participants:

Demographics
Past medical history

3. Bone and calendar age

4- Stage of puberty

5- Ocular examination

6. Ocular biometry

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Refraction Error	Comparison of the refraction error between the study groups	6 months
Axial Length	Comparison of the axial length between the study groups	6 months

Secondary Outcomes

Measure	Description	Time Frame
Papillitis	Comparison of the frequency of papillitis between the study groups	6 months
Central Corneal Thickness	Comparison of the mean central corneal thickness between the study groups

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

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:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

11 Years

Standard Ages

Child

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohsen Pourazizi, MD	Contact	00983134452036		m.pourazizi@med.mui.ac.ir

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Isfahan University of Medical Sciences	Recruiting	Isfahan		+98	Iran

Condition Browse Module

MeSH Terms

ID	Term
D011629	Puberty, Precocious
D012030	Refractive Errors

Ancestor Terms

ID	Term
D006058	Gonadal Disorders
D004700	Endocrine System Diseases
D005128	Eye Diseases

Browse Leaves

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Browse Branches

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