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

Sponsor
Batman Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05920655
Collaborator
(none)
100
1
16
6.2

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Optic coherence tomography

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Comparison of Ocular Changes by Surgical Menopause Using Optical Coherence Tomography (OCT)
Actual Study Start Date :
Feb 12, 2022
Actual Primary Completion Date :
Jun 1, 2023
Actual Study Completion Date :
Jun 15, 2023

Arms and Interventions

Arm Intervention/Treatment
1( Surgical menopause)

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

Diagnostic Test: Optic coherence tomography
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

Diagnostic Test: Optic coherence tomography
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

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

Outcome Measures

Primary Outcome Measures

  1. Effect of surgical menopause on corneal and macular thickness [6 months after hysterectomy and bilateral salpingo-oopherectomy]

    To question the effect on macular and corneal thickness secondary to sudden ovarian hormone change with surgical menopause.

Secondary Outcome Measures

  1. Eye examination needed after surgical menopause [6-12 months]

    To seek an answer to the question of adding eye diseases examination to the examinations of post-surgical menopause patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 55 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Batman education adn research hospital Batman Turkey 72100

Sponsors and Collaborators

  • Batman Training and Research Hospital

Investigators

  • Principal Investigator: Erhan Okuyan, Batman Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Erhan Okuyan,M.D, M.D, Batman Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT05920655
Other Study ID Numbers:
  • 2023
First Posted:
Jun 27, 2023
Last Update Posted:
Jun 27, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 27, 2023