NCT07419776

The Effect Of Polycystic Ovarian Syndrome Treatment On Ocular Surface.

The Effect Of Polycystic Ovarian Syndrome Treatment On Ocular Surface

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 90 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Poly Cystic Ovary Syndrome

Interventions

Type	Name	Description
DEVICE	dry eye diagnostic system of Mediworks	* 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.
DEVICE	Optical coherence tomography angiography	* 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.
DRUG	Contraceptives, Oral, Combined	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
DRUG	Clomiphene Citrate 50 mg	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)

Timeline

• Start date: 2023-06-24
• Primary completion: 2025-11-20
• Completion: 2025-11-20
• First posted: 2026-02-19
• Last updated: 2026-02-19

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study
• FDA-regulated device study