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Poly Cystic Ovary SyndromeNCT07419776

The Effect Of Polycystic Ovarian Syndrome Treatment On Ocular Surface.

An observational study of Poly Cystic Ovary Syndrome, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Poly Cystic Ovary Syndrome
What is being tested?
dry eye diagnostic system of Mediworks, Optical coherence tomography angiography and Contraceptives, Oral, Combined
How many people
90 participants
Where
1 siteEgypt
Study dates
24 Jun 2023to 20 Nov 2025
How long will I take part?
6 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Kasr Alainy hospital

    Cairo

Other trials in Egypt

About this study

Official title: 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:

Read more
  • 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.
Read the 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
Being tested
dry eye diagnostic system of Mediworks, Optical coherence tomography angiography, Contraceptives, Oral, Combined, Clomiphene Citrate 50 mg
Keywords
Polycystic ovary syndrome, ocular surface, PCOS, oral contraceptive pills, COCPs, clomiphene citrate, Dry eye, OCTA, optical coherence tomography angiography
Medical subject headings
Polycystic Ovary Syndrome, Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dry eye diagnostic system of MediworksDevice

    • 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 angiographyDevice

    • 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, CombinedDrug

    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 mgDrug

    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)

Study groups in NCT07419776
Study groupRoleWhat they receive
Control30 control females with no relevant medical, gynecological or ophthalmic history
Receives: Device: dry eye diagnostic system of Mediworks; Device: Optical coherence tomography angiography
PCOS group on COCPs30 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)
Receives: Device: dry eye diagnostic system of Mediworks; Device: Optical coherence tomography angiography; Drug: Contraceptives, Oral, Combined
PCOS group on Clomiphene citrate30 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)
Receives: Device: dry eye diagnostic system of Mediworks; Device: Optical coherence tomography angiography; Drug: Clomiphene Citrate 50 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 6 months

  2. 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.

    Measured: 6 months

  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

    using dry eye diagnostic system

    Measured: 6 months

  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

    using dry eye diagnostic system

    Measured: 6 months

  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

    using OCTA

    Measured: 6 months

  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.

    using OCTA

    Measured: 6 months

Secondary outcomes (5)
  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.

    using dry eye diagnostic system

    Measured: 6 months

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

    using dry eye diagnostic system

    Measured: 6 months

  3. 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.

    Measured: 6 months

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

    using OCTA

    Measured: 6 months

  5. 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)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2026
  2. Study start24 Jun 2023
  3. Primary completion20 Nov 2025
  4. Study completion20 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
90 participants (actual)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07419776
Sponsor's protocol ID
MD-404-2022
Status last verified
Feb 2026
First submitted
4 Feb 2026
Last updated
19 Feb 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
Yes: ll IPD collected throughout the trial

Questions about this trial

What is this clinical trial studying?

An observational study of Poly Cystic Ovary Syndrome, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measuring changes in Meibomian glands functions in polycystic ovarian syndrome and with different drugs used in managing it. (time frame: 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.

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