Ocular Findings of Polycystic Ovary Syndrome

Sponsor

Istanbul Medeniyet University (Other)

Overall Status

Completed

CT.gov ID

NCT03896841

Collaborator

(none)

Enrollment

60.4

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Other: Observation

Study Design

Study Type:

Observational

Actual Enrollment :

38 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Ocular Surface Disease Test Results, Corneal Biomechanical Properties, and Structural Parameters in Patients With Polycystic Ovary Syndrome

Actual Study Start Date :

Mar 17, 2013

Actual Primary Completion Date :

Mar 20, 2014

Actual Study Completion Date :

Mar 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
PCOS premenopausal patients with PCOS	Other: Observation Ocular Findings Observations
control subjects non-pregnant healthy control subjects	Other: Observation Ocular Findings Observations

Arm

Intervention/Treatment

PCOS

premenopausal patients with PCOS

Other: Observation

Ocular Findings Observations

control subjects

non-pregnant healthy control subjects

Other: Observation

Ocular Findings Observations

Outcome Measures

Primary Outcome Measures

Comparison of the anterior segment parameter results (Pentacam). [1 year]
measurement of the central corneal thickness.
Comparison of the corneal biomechanical parameter results (ocular response analyzer). [1 year]
measurement of the corneal hysteresis (CH).

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 43 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Istanbul Medeniyet University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT03896841

Other Study ID Numbers:

25801608

First Posted:

Apr 1, 2019

Last Update Posted:

Apr 1, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Polycystic Ovary Syndrome

Syndrome

Study Results

No Results Posted as of Apr 1, 2019