Ocular Findings of Polycystic Ovary Syndrome | NCT03896841

Studies
Ocular Findings of Polycystic Ovary Syndrome

NCT03896841

Sponsor

Istanbul Medeniyet University

Status

Completed

Last Update Posted

Apr 1, 2019Actual

Enrollment

38Actual

Phase

Not provided

Conditions

Polycystic Ovary Syndrome

Interventions

Observation

Countries

Not provided

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

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 17, 2013Actual

Primary Completion Date

Mar 20, 2014Actual

Completion Date

Mar 30, 2018Actual

First Submitted Date

Jan 13, 2019

First Submission Date that Met QC Criteria

Mar 28, 2019

First Posted Date

Apr 1, 2019Actual

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

Mar 28, 2019

Last Update Posted Date

Apr 1, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mustafa Hepokur, Medical Doctor, Clinical Investigator, Istanbul Medeniyet UniversityPrincipal Investigator

Lead Sponsor

Istanbul Medeniyet UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Purpose: This study aimed to compare the ocular surface disease test results, anterior segment parameters, and ocular response analyzer (ORA) findings of polycystic ovary syndrome (PCOS) patients with those of healthy reproductive age female controls.

Detailed Description

Not provided

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

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PCOS		premenopausal patients with PCOS	Other: Observation
control subjects		non-pregnant healthy control subjects	Other: Observation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observation	Other	Ocular Findings Observations	PCOS control subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of the anterior segment parameter results (Pentacam).	measurement of the central corneal thickness.	1 year
Comparison of the corneal biomechanical parameter results (ocular response analyzer).	measurement of the corneal hysteresis (CH).	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

premenopausal with PCOS

Exclusion Criteria:

patients with external ocular disease other than dry eye complaints,
use of topical drops that can affect the tear film layer,
contact lens use histories,
those who received hormone therapy for 6 months,
those who have systemic medication or systemic disease that may affect the tear film layer and reproductive physiology,
previous eye surgeries,
smokers and alcohol users,
those having diseases (Cushing's syndrome or androgen-secreting tumors) causing similar clinical findings.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

43 Years

Standard Ages

Adult

Study Population

This was a prospective, case-control study in which 23 premenopausal patients with PCOS diagnoses and 15 non-pregnant healthy control subjects were included.

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011085	Polycystic Ovary Syndrome

Ancestor Terms

ID	Term
D010048	Ovarian Cysts
D003560	Cysts
D009369	Neoplasms
D010049	Ovarian Diseases
D000291

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D019370	Observation

Ancestor Terms

ID	Term
D008722	Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided