The Effect Of Polycystic Ovarian Syndrome Treatment On Ocular Surface
概览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Measuring changes in Meibomian glands functions in polycystic ovarian syndrome and with different drugs used in managing it.
概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females at child bearing period (18-40 years old)
- •Patients recently diagnosed with polycystic ovarian syndrome..
排除标准
- •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.
研究组 & 干预措施
Control
30 control females with no relevant medical, gynecological or ophthalmic history
干预措施: Optical coherence tomography angiography (Device)
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)
干预措施: dry eye diagnostic system of Mediworks (Device)
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)
干预措施: Optical coherence tomography angiography (Device)
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)
干预措施: Contraceptives, Oral, Combined (Drug)
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)
干预措施: dry eye diagnostic system of Mediworks (Device)
Control
30 control females with no relevant medical, gynecological or ophthalmic history
干预措施: dry eye diagnostic system of Mediworks (Device)
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)
干预措施: Optical coherence tomography angiography (Device)
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)
干预措施: Clomiphene Citrate 50 mg (Drug)
结局指标
主要结局
Measuring changes in Meibomian glands functions in polycystic ovarian syndrome and with different drugs used in managing it.
时间窗: 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
Measuring changes in lipid layer thickness in polycystic ovarian syndrome and with different drugs used in managing it
时间窗: 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.
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
时间窗: 6 months
using dry eye diagnostic system
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
时间窗: 6 months
using dry eye diagnostic system
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
时间窗: 6 months
using OCTA
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.
时间窗: 6 months
using OCTA
次要结局
- 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)
研究者
Mohamed Saad
specialist of ophthalmology
Cairo University