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

NCT ID: NCT05920655

Last Updated: 2023-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-12

Study Completion Date

2023-06-15

Brief Summary

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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

Detailed Description

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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.

Conditions

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Corneal Deformity Macular Degeneration Advanced Surgical Menopause

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1( Surgical menopause)

Surgical menopause : At least 6 months after hysterectomy and salphingo-oopherectomy

Optic coherence tomography

Intervention Type DIAGNOSTIC_TEST

Eye examination of patients with optic coherence tomography test by an ophthalmologist

2 ( Natural menopause )

Natural menopause :Healthy female patients who have not had a menstrual period for at least 1 year and have not received any treatment for this reason before

Optic coherence tomography

Intervention Type DIAGNOSTIC_TEST

Eye examination of patients with optic coherence tomography test by an ophthalmologist

3 (Control )

Healthy women aged 30-45 years with regular menstrual cycles and no symptoms of menopause

Optic coherence tomography

Intervention Type DIAGNOSTIC_TEST

Eye examination of patients with optic coherence tomography test by an ophthalmologist

Interventions

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Optic coherence tomography

Eye examination of patients with optic coherence tomography test by an ophthalmologist

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Batman Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Erhan Okuyan,M.D

M.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erhan Okuyan

Role: PRINCIPAL_INVESTIGATOR

Batman Training and Research Hospital

Locations

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Batman education adn research hospital

Batman, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2023

Identifier Type: -

Identifier Source: org_study_id

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