Comparison of Ocular Changes by Surgical Menopause Using Optical Coherence Tomography (OCT)

Surgical Menopause Clinical Trial

Official title:

Comparison of Ocular Changes by Surgical Menopause Using Optical Coherence Tomography (OCT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05920655
• Other study ID #: 2023
• Status: Completed
• Start date: February 12, 2022
• Est. completion date: June 15, 2023

Study information

• Verified date: June 2023
• Source: Batman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to investigate the early changes in macular thickness, corneal thickness and intraocular pressure in young women undergoing surgical menopause.

Methods: Eye findings of 30 surgical menopausal (Postoperative 3-6 months) and 48 natural menopause and 22 healty women (control) were evaluated using OCT. Women with no known eye disease, no chronic disease (Diabetes Mellitus, Cardiac Disease any Autoimmune disease) and no migraine in addition to non smokers were included in the study. Women using any hormone and obese women ( BMI >25 kg/m2) were excluded. Macular and corneal thickness and intraocular pressure (IOP) were measured in both eyes of the women

Description:

This prospective case control study was conducted in a tertiary gynecology and obstetrics clinic and eye clinic between 2020 and 2021 with ethics committee approval number 2020 250 ). Informed consent form was obtained from all participants. All participants were outpatients who applied to obstetrics clinic in Batman Training and Research Hospital.

The study started with 105 patient. Based on the study exclusion criteria, 7 patients were excluded from the study. Every patient in the surgical menopause group underwent a hysterectomy and bilateral salpingo-oophorectomy for benign uterine reasons. The patients included in the study were menstruating women with preoperative natural ovarian appearance and benign non ovarian indications, who had undergone hysterectomy and bilateral salpingo-oophorectomy and had no preoperative menopause complaints. Patients younger than 52 years of age who have undergone oophorectomy are patients whose ovaries have been removed either because of patient anxiety due to a family history of cancer or because of adhesions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 15, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 55 Years

Eligibility

Inclusion Criteria:

• The patients included in the study were menstruating women with preoperative natural ovarian appearance and benign non ovarian indications, who had undergone hysterectomy and bilateral salpingo-oopherectomy, and had no preoperative menopause complaints. Patients younger than 52 years of age who have undergone oophorectomy are patients whose ovaries have been removed either because of patient anxiety due to a family history of cancer or because of adhesions.

• having a healthy child

• have consented to participate in the study

Exclusion Criteria:

• Chronic disease (such as diabetes, heart disease)

• History of continuous drug use

• Unwillingness to participate in the study Being between the ages of 18-30

Related Conditions & MeSH terms

• Corneal Deformity
• Macular Degeneration
• Macular Degeneration Advanced
• Surgical Menopause

Intervention

Diagnostic Test:
• Optic coherence tomography
Eye examination of patients with optic coherence tomography test by an ophthalmologist

Locations

Country	Name	City	State
Turkey	Batman education adn research hospital	Batman

Sponsors (1)

Lead Sponsor	Collaborator
Batman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of surgical menopause on corneal and macular thickness	To question the effect on macular and corneal thickness secondary to sudden ovarian hormone change with surgical menopause.	6 months after hysterectomy and bilateral salpingo-oopherectomy
Secondary	Eye examination needed after surgical menopause	To seek an answer to the question of adding eye diseases examination to the examinations of post-surgical menopause patients.	6-12 months