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Eye Evaluation in Patients With PCOS

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ClinicalTrials.gov Identifier: NCT01950832
Recruitment Status : Completed
First Posted : September 26, 2013
Last Update Posted : September 26, 2013
Sponsor:
Information provided by (Responsible Party):
Gökhan Açmaz, Kayseri Education and Research Hospital

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.

Condition or disease Intervention/treatment
PCOS 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 124 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: Evaluation of the Macula, Retinal Nerve Fiber Layer and Choroid Thickness in Women With Polycystic Ovary Syndrome By Using Spectral-domain Optical Coherence Tomography.
Study Start Date : March 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


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 Name: Control Group

Control
60 healthy volunteers
Other: Investigating clinically normal patients with optic coherence tomography
Other Name: Control Group




Primary Outcome Measures :
  1. Macula, Retinal nerve fiber and choroid layer measurements [ Time Frame: 1 month ]
    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.


Secondary Outcome Measures :
  1. Macular thickness and volume [ Time Frame: 1 month ]
    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.


Other Outcome Measures:
  1. Retinal nerve fiber layer and choroid measurements. [ Time Frame: 1 month ]
    Temporal Superior, nasal Superior, nasal, nasal Inferior, temporal inferior parts of RNFL were evaluated



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Ages Eligible for Study:   16 Years to 43 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950832


Locations
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Turkey
Kayseri Education and Research Hospital
Kayseri, Turkey, 38039
Sponsors and Collaborators
Gökhan Açmaz
Investigators
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Principal Investigator: Gökhan Açmaz, MD Kayseri Education and Research Hospital

Additional Information:

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Responsible Party: Gökhan Açmaz, MD, Kayseri Education and Research Hospital
ClinicalTrials.gov Identifier: NCT01950832    
Other Study ID Numbers: Gökhan Açmaz
Kayseri ERH ( Other Identifier: Kayseri Education and Research Hospital )
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: September 26, 2013
Last Verified: September 2013
Keywords provided by Gökhan Açmaz, Kayseri Education and Research Hospital:
Structure of Retina
Macular Thickness
Retinal Nerve Fiber Layer
Choroidal Thickness
PCOS
Optical Coherence Tomography