The Effect Of Polycystic Ovarian Syndrome Treatment On Ocular Surface.

Initial Examination:

Patient underwent standard clinical examination and testing including:

* Full history; personal history, history of systemic diseases particularly; diabetes mellitus, hypertension, and history of ocular diseases
* Follicle stimulating hormone (FSH), luteinizing hormone (LH) , free testosterone, fasting insulin, and neutrophil to lymphocyte ratio (NLR) were obtained.
* Standard Patient Evaluation of Eye Dryness Questionnaire (SPEED) in order to quickly track the progression of dry eye symptoms over time.
* Measuring central corneal thickness (CCT) using Corneal pachymetry.
* Corrected visual acuity (using Landolt broken ring visual acuity chart(
* Pupillary light reflex.
* Intra ocular pressure (IOP) measurement (using Goldmann applanation tonometer.(
* Slit lamp examination of the anterior segment.
* Dilated fundus examination (using slit lamp biomicroscopy(
* Primary Assessment for dry eye diseases using Tear breakup time test (TBUT), break up pattern (using Fluorescein Sodium Ophthalmic Strips 0.6 mg) and Schirmer's test (using Schirmer's strips)
* Patient randomly picks one of two covered cards (one of them for right eye and the other for the left), to determine in which eye OCTA will be performed.
* Dry eye diagnostic system device (D130, Medi-Works Precision Instruments; Shanghai, China) was used to assess dry eye. Fig. 29 Corneal pachymetry.
* OCTA macula imaging were performed at the same day after dilatation of patient's pupil 3 times by tropicamide 1% (Mydriacyl® Eye drops, Alcon, Novartis, UK)
* Imaging procedures were performed by the same skilled operator .
* regarding PCOS patients, Imaging, ophthalmic examination, and laboratory tests were repeated at the same eye after 3 and 6 months

• dry eye diagnostic system of Mediworks (Device): * Dry eye diagnostic system device (D130, Medi-Works Precision Instruments; Shanghai, China) was used to assess dry eye. * Imaging procedures were performed by the same skilled operator . * regarding PCOS patients, Imaging, ophthalmic examination, and laboratory tests were repeated at the same eye after 3 and 6 months.
• Optical coherence tomography angiography (Device): * OCTA macula and optic nerve imaging were performed at the same day after dilatation of patient's pupil 3 times by tropicamide 1% (Mydriacyl® Eye drops, Alcon, Novartis, UK) * Imaging procedures were performed by the same skilled operator . * regarding PCOS patients, Imaging, ophthalmic examination, and laboratory tests were repeated at the same eye after 3 and 6 months.
• Contraceptives, Oral, Combined (Drug): 2mg Estradiol valerate and 0.5 mg Norgestrel, started on any day between day 1 and 5, given for 21 days and stopped for 7 days, course can be repeated in subsequent cycles
• Clomiphene Citrate 50 mg (Drug): as a first line of treatment for fertility indications, 50-100 mg on the second to fifth day of the menstrual cycle for 5 days, course can be repeated in subsequent cycles)

Primary outcomes

• Measuring changes in Meibomian glands functions in polycystic ovarian syndrome and with different drugs used in managing it. [6 months]: The meibomian glands loss was analyzed by the dry eye diagnostic system automatically using a built-in infrared lighting system to obtain larger image scope of the meibomian glands, Adjustable depth of field made the glands more prominent and distinguishable against the background, Meibomian glands Loss was graded accordingly
• Measuring changes in lipid layer thickness in polycystic ovarian syndrome and with different drugs used in managing it [6 months]: using dry eye diagnostic system; a white ring projection system to ensure a larger examination area, The recorded lipid layer then was compared with the standard grading template.
• Measuring changes in break up time (measured in seconds) in polycystic ovarian syndrome and with different drugs used in managing it [Time Frame: 6 months [6 months]: using dry eye diagnostic system
• Measuring changes tear meniscus height (measured in millimeters) thickness in polycystic ovarian syndrome and with different drugs used in managing it [Time Frame: 6 months [6 months]: using dry eye diagnostic system
• Measuring changes in retinal vessel density in superficial capillary plexus, deep capillary plexus, Foveal avascular zone (measured in percentage) in polycystic ovarian syndrome and with different drugs used in managing it [6 months]: using OCTA
• Measuring changes in macular thickness in superficial capillary plexus, deep capillary plexus and and RNFL thickness around the disc (measured in micrometer) in polycystic ovarian syndrome and with different drugs used in managing it. [6 months]: using OCTA

Secondary outcomes

• Measuring eye lid margin (classified according standard grading template into 4 grades) in polycystic ovarian syndrome and with different drugs used in managing it. [6 months]: using dry eye diagnostic system
• Measuring conjunctival hyperemia (measured as a percentage) in polycystic ovarian syndrome and with different drugs used in managing it. [6 months]: using dry eye diagnostic system
• Measuring ocular surface staining in polycystic ovarian syndrome and with different drugs used in managing it. [6 months]: using Dry eye diagnostic system; using a built-in yellow filter along with cobalt-blue filter, corneal sodium fluorescein images were obtained, images were classified according to look to: normal, dry spots, pooling, and stagnation.
• Measuring changes in choriocapillaris flow area (measured in squared millimeter) in polycystic ovarian syndrome and with different drugs used in managing it. [6 months]: using OCTA
• Measuring the central corneal thickness (CCT) changes in polycystic ovarian syndrome and with different drugs used in managing it [6 months]: using handheld pachymetry (measured in micrometer)

Other outcomes

• Correlating ocular changes with Luteinizing hormone to Follicle stimulating hormone ratio (LH/FSH ratio) in polycystic ovary syndrome wile using treatment. [6 months]: Normal range between 1 and 2.
• Correlate ocular changes with total testosterone in polycystic ovary syndrome, and while using its treatment. [6 months]: normal range 15:70 ng/dl
• Correlation ocular changes with neutrophil to lymphocyte ratio (NLR) (normal range 1:3) in polycystic ovary syndrome wile using treatment. [6 months]: normal range 1:3
• evaluate changes in visual acuity (using Snellen chart) in polycystic ovary syndrome, and follow up changes while using treatment regimens. [6 months]: using Snellen chart
• evaluate changes in intraocular pressure in polycystic ovary syndrome, and follow up changes while using treatment regimens. [6 months]: measured in millimeter mercury.
• evaluate changes in Standard Patient Evaluation of Eye Dryness Questionnaire in polycystic ovary syndrome, and follow up changes while using treatment regimens. [6 months]: Standard Patient Evaluation of Eye Dryness Questionnaire (SPEED) in order to quickly track the progression of dry eye symptoms over time if present, measured in score from 0-28
• measuring changes in Shermer's test in polycystic ovary syndrome patents, and while using its treatment. [6 months]: measured in millimeters.

Sex: Female, ages: 18 Years to 40 Years, accepts healthy volunteers

Inclusion Criteria:

* Females at child bearing period (18-40 years old)
* Patients recently diagnosed with polycystic ovarian syndrome..

Exclusion Criteria:

* Patients who were diagnosed with Dry eye disease.
* Patients who were treated with hormonal replacement therapy, Metformin, Aromatase inhibitors, clomiphene citrate or androgen antagonists.
* Patients who underwent ocular surgeries.
* patients with history of diabetes mellitus or hypertension.

• Study Protocol and Statistical Analysis Plan (PDF, 2022-05-01)
• Informed Consent Form (PDF, 2022-05-01)