The Effect Of Polycystic Ovarian Syndrome Treatment On Ocular Surface.

Brief summary (registry, in English)

This is a Descriptive prospective cohort study conducted at the Ophthalmology Department in Kasr-Alaini Hospital. A total of 90 subjects, 30 control females with no relevant medical, gynecological or ophthalmic history, and 60 patients with confirmed laboratory and ultrasonography diagnosis of PCOS, were recruited from "Gynecology department in Kasr Alainy hoaspital", firstly PCOS Patients were compared with the control subjects, then the PCOS group subdivided to two subgroups , First group included 30 eyes of 30 females in childbearing period (18-40 years old) scheduled for treatment for non fertility indications with oral contraceptive pills (as a first line of treatment, 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), and the second group included 30 eyes of 30 females in childbearing period (18-40 years old) scheduled for treatment with Clomiphene citrate (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), the two subdivided groups were re-examined 3 and 6 months after treatment . This study granted approval of both ophthalmology and gynecology departments and the approval of Cairo university research ethical committee. Informed consent was obtained from patients who involved in this study. 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. * Primary outcomes 1- Measuring changes in meibomian glands function, break up time, tear meniscus height, and lipid layer thickness in polycystic ovarian syndrome and with different drugs used in managing it. 2. measuring changes in retinal vessel density and macular thickness. * Secondary outcome parameters : 1. Measuring eye lid margin, conjunctival hyperemia, and ocular surface staining in polycystic ovarian syndrome and with different drugs used in managing it. 2. Measuring the central corneal thickness (CCT) changes in polycystic ovarian syndrome and with different drugs used in managing it.

What you commit to

• Study type: Observational
• Participants enrolled: 90
• From 24 Jun 2023 to the primary completion date, 20 Nov 2025
• 1 site in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

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Who the study is looking for

Age in the registry: 18 years to 40 years · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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