Polycystic Ovary SyndromeNCT03896841
Ocular Findings of Polycystic Ovary Syndrome
An observational study of Polycystic Ovary Syndrome, run by Istanbul Medeniyet University.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Observation
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 17 Mar 2013to 30 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 43 years
- Women only
- Healthy volunteers accepted
- 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.
Who may be able to join
- premenopausal with PCOS
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Observation
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Ocular Findings Observations
| Study group | Role | What they receive |
|---|---|---|
| PCOS | premenopausal patients with PCOS Receives: Other: Observation | |
| control subjects | non-pregnant healthy control subjects Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the anterior segment parameter results (Pentacam).
measurement of the central corneal thickness.
Measured: 1 year
Comparison of the corneal biomechanical parameter results (ocular response analyzer).
measurement of the corneal hysteresis (CH).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start17 Mar 2013
- Primary completion20 Mar 2014
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Hepokur, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03896841
- Sponsor's protocol ID
- 25801608
- Status last verified
- Jan 2019
- First submitted
- 13 Jan 2019
- Last updated
- 1 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Surface Disease Test Results, Corneal Biomechanical Properties, and Structural Parameters in Patients With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT03896841
- Acronym / sponsor ID
- 25801608
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 17 Mar 2013 (actual)
- Primary completion
- 20 Mar 2014 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 1 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS | – | Other: Observationpremenopausal patients with PCOS |
| control subjects | – | Other: Observationnon-pregnant healthy control subjects |
Who may qualify
- Ages
- 19 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- premenopausal with PCOS
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationOcular Findings Observations | Other | PCOS, control subjects |
Primary outcome
Comparison of the anterior segment parameter results (Pentacam).
Time frame: 1 year
measurement of the central corneal thickness.
Comparison of the corneal biomechanical parameter results (ocular response analyzer).
Time frame: 1 year
measurement of the corneal hysteresis (CH).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by Istanbul Medeniyet University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the anterior segment parameter results (Pentacam). (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2019.