NCT03896841

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 17, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2014

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2018

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 1, 2019

Completed
Last Updated

April 1, 2019

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

January 13, 2019

Last Update Submit

March 28, 2019

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

PCOS

premenopausal patients with PCOS

Other: Observation

control subjects

non-pregnant healthy control subjects

Other: Observation

Interventions

ObservationOTHER

Ocular Findings Observations

PCOScontrol subjects

Eligibility Criteria

Age19 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • premenopausal with PCOS

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Observation

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, Clinical Investigator

Study Record Dates

First Submitted

January 13, 2019

First Posted

April 1, 2019

Study Start

March 17, 2013

Primary Completion

March 20, 2014

Study Completion

March 30, 2018

Last Updated

April 1, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share