Eye Evaluation in Patients With PCOS

NCT01950832 | Completed

• 2 other identifiers: Gökhan AçmazKayseri ERH
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the macular, retinal nerve fiber layer (RNFL) and choroidal thickness alterations by using spectral-domain optical coherence tomography (SD-OCT) in polycystic ovary syndrome (PCOS) and to compare them with healthy reproductive-age women controls.

Conditions

PCOS

Keywords

Structure of Retina; Macular Thickness; Retinal Nerve Fiber Layer; Choroidal Thickness; PCOS; Optical Coherence Tomography

Outcome Measures

Primary Outcomes (1)

• Macula, Retinal nerve fiber and choroid layer measurements

  Each subject underwent a comprehensive ophthalmologic examination. Following this detailed ophthalmologic examination, the third-generation Spectralis OCT device (software version 5.6.3.0; Spectralis OCT Heidelberg Engineering, Dossenheim, Germany) was used for the assessment. The OCT assessments of involved in the study were performed by the same experienced technician. The procedure was achieved without pupillary dilatation and under the same intensity of dim room lighting.

  1 month

Secondary Outcomes (1)

• Macular thickness and volume

  1 month

Other Outcomes (1)

• Retinal nerve fiber layer and choroid measurements.

  1 month

Study Arms (2)

polycystic ovary syndrome (PCOS) group

Patients who were diagnosed as PCOS according to 2003 Rotterdam Criteria.

Other: Investigating clinically normal patients with optic coherence tomography

Control

60 healthy volunteers

Other: Investigating clinically normal patients with optic coherence tomography

Interventions

Investigating clinically normal patients with optic coherence tomography OTHER

Also known as: Control Group

Control; polycystic ovary syndrome (PCOS) group

Eligibility Criteria

• Age: 16 Years - 43 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Participants: Patients who were diagnosed with PCOS according to 2003 Rotterdam Criteria, had no physical disease but PCOS, did not receive any treatment for 6 months prior to the study for PCOS or co-morbidities and had at least primary school degre will enroll into the study. The second group consisted of 60 healthy volunteer participants in reproductive age.

You may qualify if:

• Patients who were diagnosed as PCOS according to 2003 Rotterdam Criteria, had no physical disease but PCOS, did not receive any treatment for 6 months prior to the study for PCOS or for co-morbidities and had at least primary school degree.

You may not qualify if:

• Patients who had thyroid disorders, hypertension, thromboembolic disease, diabetes mellitus, cardiovascular events, Cushing' disease, positive malignancy, congenital adrenal hyperplasia, liver disease,psychotic disorders and used antidepressants or steroidal hormone drugs and mood stabilizers (Li, Valproic acid, COCs, antiandrogens or insulin sensitizers etc.)

Sponsors & Collaborators

• Gökhan Açmaz: lead

Study Sites (1)

Kayseri Education and Research Hospital

Kayseri, 38039, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Gökhan Açmaz, MD

  Kayseri Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 17, 2013
• First Posted: September 26, 2013
• Study Start: March 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 26, 2013

Record last verified: 2013-09

Locations

TU (1)