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

NCT05920655 | Completed

• 1 other identifier: 2023
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Corneal Deformity; Macular Degeneration Advanced; Surgical Menopause

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Eye examination needed after surgical menopause

  6-12 months

Study Arms (3)

1( Surgical menopause)

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

Diagnostic Test: Optic coherence tomography

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

3 (Control )

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

Diagnostic Test: Optic coherence tomography

Interventions

Optic coherence tomography DIAGNOSTIC_TEST

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

1( Surgical menopause); 2 ( Natural menopause ); 3 (Control )

Eligibility Criteria

• Age: 30 Years - 55 Years
• Gender Eligibility Details: Female ,age between 30-55 .
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Batman Training and Research Hospital: lead

Study Sites (1)

Batman education adn research hospital

Batman, 72100, Turkey (Türkiye)

Location

Study Officials

• Erhan Okuyan

  Batman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D

Study Record Dates

• First Submitted: June 17, 2023
• First Posted: June 27, 2023
• Study Start: February 12, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 15, 2023
• Last Updated: June 27, 2023

Record last verified: 2023-06

Locations

TU (1)