Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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 :
Initial Examination:
Patient underwent standard clinical examination and testing including:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | 30 control females with no relevant medical, gynecological or ophthalmic history |
| |
| 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) |
| |
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dry eye diagnostic system of Mediworks | Device |
|
| 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. |
| 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. |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr Alainy hospital | Cairo | Egypt |
Not provided
| Label | URL |
|---|---|
| Association Between Dry Eye and Polycystic Ovary Syndrome: Subclinical Inflammation May Be Part of the Process | View source |
| Optical Coherence Tomography Angiography Findings in Polycystic Ovary Syndrome | View source |
Not provided
ll IPD collected throughout the trial
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 1, 2022 | Feb 11, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 1, 2022 | Feb 11, 2026 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
Not provided
Not provided
| ID | Term |
|---|---|
| D003277 | Contraceptives, Oral, Combined |
| D002996 | Clomiphene |
| ID | Term |
|---|---|
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D003276 | Contraceptives, Oral |
| D003271 | Contraceptive Agents, Female |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Optical coherence tomography angiography | Device |
|
|
| 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) |
|
using OCTA |
| 6 months |
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 |
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 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |