Eye Evaluation in Patients With PCOS

Evaluation of the Macula, Retinal Nerve Fiber Layer and Choroid Thickness in Women With Polycystic Ovary Syndrome By Using Spectral-domain Optical Coherence Tomography.

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.

Study Overview

• Status: Completed
• Conditions: PCOS
• Intervention / Treatment: Other: Investigating clinically normal patients with optic coherence tomography

Detailed Description

PCOS was diagnosed according to Rotterdam criteria that include (i) oligomenorrhea (interval between periods was ≥35 days) or amenorrhea (absence of vaginal bleeding for 6 months); (ii) hyperandrogenism; (iii) polycystic ovaries and exclusion of other PCOS-like syndromes, such as adrenal dysfunction, Cushing's syndrome, congenital adrenal hyperplasia, androgen-secreting tumors, enzyme deficiency (21-hydroxylase in particular), hyperprolactinemia, and thyroid dysfunction. Ultrasonographic diagnosis of polycystic ovaries was based on the presence of multiple cysts (≥12 small follicles in each ovary [2-9 mm in diameter]) arranged peripherally and scattered throughout the dense core of stroma (the necklace appearance of follicular cysts), and/or increased ovarian volume >10 ml on pelvic or vaginal ultrasound examination.

Patients who were allocated in control group had regular menstrual cycle and normal ovarian morphology detected by ultrasounds. None of the participants in both groups were pregnant. All patients were evaluated in follicular phase of their menstrual cycle.

Each subject underwent a comprehensive ophthalmologic examination. Following this detailed ophthalmologic examination, the third-generation Spectralis OCT device 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.

Macular thickness was determined automatically and was analyzed by OCT software. Fast Macular Thickness Map option was utilized for the macular measurements. During the assessments, macular thickness and volume analysis were used. We selected the macular map analysis protocol on the Spectralis to display numeric averages of the measurements for each of the 9 subfields as defined by the Early Treatment Diabetic Retinopathy Study (ETDRS) The peripapillary RNFL thickness parameters that were automatically calculated by the fast RNFL mode and divided into regions included temporal quadrant thickness, temporal superior quadrant thickness, nasal superior quadrant thickness, nasal quadrant thickness, nasal inferior quadrant thickness, temporal inferior quadrant thickness, and average thickness.

The method of obtaining enhanced depth imaging (EDI) OCT images has been reported previously. The resultant images were viewed and measured with the contained Heidelberg Eye Explorer software. Choroid imaging was obtained by activating the EDI button. The choroid was manually measured from the outer border of the hyperreflective line corresponding to the retinal pigment epithelium to the inner surface of the sclera. The measurements of subfoveal choroidal thickness were done by one of the authors in a masked fashion without knowledge of subject information.

• Study Type: Observational
• Enrollment (Actual): 124

Contacts and Locations

Study Locations

• Turkey
  • Kayseri, Turkey, 38039
    • Kayseri Education and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Other Names: Control Group
Control; 60 healthy volunteers	Other: Investigating clinically normal patients with optic coherence tomography; Other Names: Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macular thickness and volume	Central subfield, inferior inner macula, inferior outer macula, nasal inner macula, nasal outer macula, superior inner macula, superior outer macula, temporal inner macula, temporal outer maculas both thickness and volumes were evaluated.	1 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retinal nerve fiber layer and choroid measurements.	Temporal Superior, nasal Superior, nasal, nasal Inferior, temporal inferior parts of RNFL were evaluated	1 month

Collaborators and Investigators

• Sponsor: Gökhan Açmaz
• Investigators: Principal Investigator: Gökhan Açmaz, MD, Kayseri Education and Research Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: September 17, 2013
• First Submitted That Met QC Criteria: September 19, 2013
• First Posted (Estimate): September 26, 2013

Study Record Updates

• Last Update Posted (Estimate): September 26, 2013
• Last Update Submitted That Met QC Criteria: September 19, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: PCOS; Optical Coherence Tomography; Macular Thickness; Retinal Nerve Fiber Layer; Choroidal Thickness; Structure of Retina
• Other Study ID Numbers: Gökhan Açmaz; Kayseri ERH (Other Identifier: Kayseri Education and Research Hospital)