Ocular Findings of Polycystic Ovary Syndrome

March 28, 2019 updated by: Mustafa Hepokur, Istanbul Medeniyet University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

38

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Medeniyet University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2013

Primary Completion (Actual)

March 20, 2014

Study Completion (Actual)

March 30, 2018

Study Registration Dates

First Submitted

January 13, 2019

First Submitted That Met QC Criteria

March 28, 2019

First Posted (Actual)

April 1, 2019

Study Record Updates

Last Update Posted (Actual)

April 1, 2019

Last Update Submitted That Met QC Criteria

March 28, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25801608

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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