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Completed

NCT Number: NCT07419776

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.

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Key information

Conditions

Poly Cystic Ovary Syndrome Adnexal Diseases Cysts Dry Eye Syndromes Endocrine System Diseases Eye Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Lacrimal Apparatus Diseases Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Kasr Alainy hospital

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. Measuring changes in Meibomian glands functions in polycystic ovarian syndrome and with different drugs used in managing it.

    Time frame: 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

  2. Measuring changes in lipid layer thickness in polycystic ovarian syndrome and with different drugs used in managing it

    Time frame: 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.

  3. 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

    Time frame: 6 months

    using dry eye diagnostic system

  4. 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

    Time frame: 6 months

    using dry eye diagnostic system

  5. 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

    Time frame: 6 months

    using OCTA

  6. 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.

    Time frame: 6 months

    using OCTA

Secondary outcomes

  1. Measuring eye lid margin (classified according standard grading template into 4 grades) in polycystic ovarian syndrome and with different drugs used in managing it.

    Time frame: 6 months

    using dry eye diagnostic system

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

    Time frame: 6 months

    using dry eye diagnostic system

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

    Time frame: 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.

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

    Time frame: 6 months

    using OCTA

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

    Time frame: 6 months

    using handheld pachymetry (measured in micrometer)

Other outcomes

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

    Time frame: 6 months

    Normal range between 1 and 2.

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

    Time frame: 6 months

    normal range 15:70 ng/dl

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

    Time frame: 6 months

    normal range 1:3

  4. evaluate changes in visual acuity (using Snellen chart) in polycystic ovary syndrome, and follow up changes while using treatment regimens.

    Time frame: 6 months

    using Snellen chart

  5. evaluate changes in intraocular pressure in polycystic ovary syndrome, and follow up changes while using treatment regimens.

    Time frame: 6 months

    measured in millimeter mercury.

  6. evaluate changes in Standard Patient Evaluation of Eye Dryness Questionnaire in polycystic ovary syndrome, and follow up changes while using treatment regimens.

    Time frame: 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

  7. measuring changes in Shermer's test in polycystic ovary syndrome patents, and while using its treatment.

    Time frame: 6 months

    measured in millimeters.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

The Effect Of Polycystic Ovarian Syndrome Treatment On Ocular Surface

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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