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

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

Study Overview

• Status: Completed
• Conditions: Corneal Deformity; Surgical Menopause; Macular Degeneration Advanced
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Turkey
  • Batman, Turkey, 72100
    • Batman education adn research hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patient selection was made between surgical menopause, natural menopause and healthy women who have given birth before.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2022
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 15, 2023

Study Registration Dates

• First Submitted: June 17, 2023
• First Submitted That Met QC Criteria: June 17, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 17, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: 2023 (Other Grant/Funding Number: GRAMMY Museum Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Will be given to the journal upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No