Eye Evaluation in Patients With PCOS
Condition: PCOS
Study type: Observational [Patient Registry]

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.
    

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.
    

Intervention name(s): Investigating clinically normal patients with optic coherence tomography
Intervention type(s): Other
Other intervention name(s): Control Group
Observational model: Case-Control
Time perspective: Prospective
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.
      
Keywords: Structure of Retina; Macular Thickness; Retinal Nerve Fiber Layer; Choroidal Thickness; PCOS; Optical Coherence Tomography