The Effect Of Polycystic Ovarian Syndrome Treatment On Ocular Surface.

The Effect Of Polycystic Ovarian Syndrome Treatment On Ocular Surface

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.

Study Overview

• Status: Completed
• Conditions: Poly Cystic Ovary Syndrome
• Intervention / Treatment: Device: dry eye diagnostic system of Mediworks; Device: Optical coherence tomography angiography; Drug: Contraceptives, Oral, Combined; Drug: Clomiphene Citrate 50 mg

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

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Kasr Alainy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

90 females, 30 of them with no previous medical or surgical history of importance 60 of them with confirmed laboratory and ultrasonography diagnosis of PCOS; 30 for cocps treatment and 30 for clomiphene citrate.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control; 30 control females with no relevant medical, gynecological or ophthalmic history	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.
PCOS group on COCPs; 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)	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
PCOS group on Clomiphene citrate; 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)	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: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring changes in Meibomian glands functions in polycystic ovarian syndrome and with different drugs used in managing it.	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	6 months
Measuring changes in lipid layer thickness in polycystic ovarian syndrome and with different drugs used in managing it	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.	6 months
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	using dry eye diagnostic system	6 months
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	using dry eye diagnostic system	6 months
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	using OCTA	6 months
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.	using OCTA	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measuring eye lid margin (classified according standard grading template into 4 grades) in polycystic ovarian syndrome and with different drugs used in managing it.	using dry eye diagnostic system	6 months
Measuring conjunctival hyperemia (measured as a percentage) in polycystic ovarian syndrome and with different drugs used in managing it.	using dry eye diagnostic system	6 months
Measuring ocular surface staining in polycystic ovarian syndrome and with different drugs used in managing it.	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.	6 months
Measuring changes in choriocapillaris flow area (measured in squared millimeter) in polycystic ovarian syndrome and with different drugs used in managing it.	using OCTA	6 months
Measuring the central corneal thickness (CCT) changes in polycystic ovarian syndrome and with different drugs used in managing it	using handheld pachymetry (measured in micrometer)	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlating ocular changes with Luteinizing hormone to Follicle stimulating hormone ratio (LH/FSH ratio) in polycystic ovary syndrome wile using treatment.	Normal range between 1 and 2.	6 months
Correlate ocular changes with total testosterone in polycystic ovary syndrome, and while using its treatment.	normal range 15:70 ng/dl	6 months
Correlation ocular changes with neutrophil to lymphocyte ratio (NLR) (normal range 1:3) in polycystic ovary syndrome wile using treatment.	normal range 1:3	6 months
evaluate changes in visual acuity (using Snellen chart) in polycystic ovary syndrome, and follow up changes while using treatment regimens.	using Snellen chart	6 months
evaluate changes in intraocular pressure in polycystic ovary syndrome, and follow up changes while using treatment regimens.	measured in millimeter mercury.	6 months
evaluate changes in Standard Patient Evaluation of Eye Dryness Questionnaire in polycystic ovary syndrome, and follow up changes while using treatment regimens.	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	6 months
measuring changes in Shermer's test in polycystic ovary syndrome patents, and while using its treatment.	measured in millimeters.	6 months

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

Helpful Links

• Association Between Dry Eye and Polycystic Ovary Syndrome: Subclinical Inflammation May Be Part of the Process
• Optical Coherence Tomography Angiography Findings in Polycystic Ovary Syndrome

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2023
• Primary Completion (Actual): November 20, 2025
• Study Completion (Actual): November 20, 2025

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 11, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: OCTA; PCOS; Polycystic ovary syndrome; Dry eye; ocular surface; clomiphene citrate; optical coherence tomography angiography; oral contraceptive pills; COCPs
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Eye Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts; Cysts; Lacrimal Apparatus Diseases; Polycystic Ovary Syndrome; Dry Eye Syndromes; Physiological Effects of Drugs; Reproductive Control Agents; Contraceptive Agents, Female; Contraceptive Agents; Contraceptives, Oral; Organic Chemicals; Pharmaceutical Preparations; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Benzene Derivatives; Drug Combinations; Stilbenes; Benzylidene Compounds; Clomiphene; Contraceptives, Oral, Combined
• Other Study ID Numbers: MD-404-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: ll IPD collected throughout the trial
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes