The Effect Of Polycystic Ovarian Syndrome Treatment On Ocular Surface.

NCT07419776 | Completed FDA Drug FDA Device

• 1 other identifier: MD-404-2022
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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 :
• Measuring eye lid margin, conjunctival hyperemia, and ocular surface staining in polycystic ovarian syndrome and with different drugs used in managing it.
• Measuring the central corneal thickness (CCT) changes in polycystic ovarian syndrome and with different drugs used in managing it.

Conditions

Poly Cystic Ovary Syndrome

Keywords

Polycystic ovary syndrome; ocular surface; PCOS; oral contraceptive pills; COCPs; clomiphene citrate; Dry eye; OCTA; optical coherence tomography angiography

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• 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

• Measuring conjunctival hyperemia (measured as a percentage) in polycystic ovarian syndrome and with different drugs used in managing it.

  6 months

• Measuring ocular surface staining in polycystic ovarian syndrome and with different drugs used in managing it.

  6 months

• Measuring changes in choriocapillaris flow area (measured in squared millimeter) in polycystic ovarian syndrome and with different drugs used in managing it.

  6 months

• Measuring the central corneal thickness (CCT) changes in polycystic ovarian syndrome and with different drugs used in managing it

  6 months

Other Outcomes (7)

• Correlating ocular changes with Luteinizing hormone to Follicle stimulating hormone ratio (LH/FSH ratio) in polycystic ovary syndrome wile using treatment.

  6 months

• Correlate ocular changes with total testosterone in polycystic ovary syndrome, and while using its treatment.

  6 months

• Correlation ocular changes with neutrophil to lymphocyte ratio (NLR) (normal range 1:3) in polycystic ovary syndrome wile using treatment.

  6 months

Study Arms (3)

Control

30 control females with no relevant medical, gynecological or ophthalmic history

Device: dry eye diagnostic system of Mediworks; Device: Optical coherence tomography angiography

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; Device: Optical coherence tomography angiography; Drug: Contraceptives, Oral, Combined

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; Device: Optical coherence tomography angiography; Drug: Clomiphene Citrate 50 mg

Interventions

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.

Control; PCOS group on COCPs; PCOS group on Clomiphene citrate

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.

Control; PCOS group on COCPs; PCOS group on Clomiphene citrate

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

PCOS group on COCPs

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)

PCOS group on Clomiphene citrate

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy hospital

Cairo, Egypt

Location

Related 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

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Dry Eye Syndromes

Interventions

Contraceptives, Oral, Combined; Clomiphene

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Drug Combinations; Pharmaceutical Preparations; Contraceptives, Oral; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: specialist of ophthalmology

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 19, 2026
• Study Start: June 24, 2023
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE

Locations

EG (1)