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Ocular Findings of Polycystic Ovary Syndrome

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ClinicalTrials.gov Identifier: NCT03896841
Recruitment Status : Completed
First Posted : April 1, 2019
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Mustafa Hepokur, Istanbul Medeniyet University

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
Polycystic Ovary Syndrome Other: Observation

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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 : March 17, 2013
Actual Primary Completion Date : March 20, 2014
Actual Study Completion Date : March 30, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Comparison of the anterior segment parameter results (Pentacam). [ Time Frame: 1 year ]
    measurement of the central corneal thickness.

  2. Comparison of the corneal biomechanical parameter results (ocular response analyzer). [ Time Frame: 1 year ]
    measurement of the corneal hysteresis (CH).



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Ages Eligible for Study:   19 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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.

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Responsible Party: Mustafa Hepokur, Medical Doctor, Clinical Investigator, Istanbul Medeniyet University
ClinicalTrials.gov Identifier: NCT03896841     History of Changes
Other Study ID Numbers: 25801608
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases