Comparison of Ocular Findings in Patients Between Surgical and Natural Menopause

It is aimed to compare the ocular findings in patients with natural and surgical menopause.

Study Overview

• Status: Completed
• Conditions: Macula Edema; Menopause Surgical; Visual Acuity Reduced Transiently
• Intervention / Treatment: Diagnostic test: measurement of macular thickness, corneal thickness and lens opacities

Detailed Description

To compare the parameters such as fundus examination, macular thickness, visual acuity and lens opacities among female patients diagnosed with menopause between the ages of 40-65.The criteria for exclusion from the study are the presence of a history of illness, drug use, smoking and alcohol use.Inclusion criteria were female patients who were in menopause and who did not use any medications. For surgical menopause, the uterus and ovaries were surgically removed at least 3 months ago.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Turkey
  • Batman, Turkey, 72000
    • Batman Maternity and Child Health Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Will be studied in a patient population with low sociocultural level.

Description

Inclusion Criteria:

• Newly diagnosed menopause (Natural or Surgical Menopause( At least 3 months after surgery),
• No history of illness(Diabetes,Heart disease,Kidney disease etc.)
• Not Smoking
• Did not use alcohol
• Have not use any medication
• Age between 45-65 years
• BMI between 20-25 kg/m

Exclusion Criteria:

• Smoking or Alchohol consumption
• Age before 45 and after 65 years
• Have chronic disease
• Using any medication
• Have not diagnosed Menopause
• BMI greater than 30 kg/m

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Natural menopause(Control group); Female patients between 45-60 years of age diagnosed with menopause without any intervention	Diagnostic test: measurement of macular thickness, corneal thickness and lens opacities; The incidence of macular thickness, Corneal thickness, intraocular pressure and lens opacities will be investigated by an ophthalmologist.
Surgical Menopause (Case group); Female patients aged 45-60 years included in the study 3 months after bilateral oophorectomy and hysterectomy	Diagnostic test: measurement of macular thickness, corneal thickness and lens opacities; The incidence of macular thickness, Corneal thickness, intraocular pressure and lens opacities will be investigated by an ophthalmologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macular thickness measurement	Macular thickness(micron) in both eyes will be measured by optical coherence tomography,	3 months after menopause
Detecting lens opacities	Lens opacities (Grade 1,2,3,4) will be measured by indirect biomicroscopy,	3 months after menopause
Intraocular pressure measurement	Intraocular pressures( mm Hg) will be measured and recorded with the applanation tonometry device.	3 months after menopause
Comparison of all detected data	All numerical data will be analyzed and compared with relevant statistical tests and the p value will be accepted as less than 0.05 to be considered a statistically significant difference.	3 months after menopause

Collaborators and Investigators

• Sponsor: Batman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): March 23, 2022
• Study Completion (Actual): March 23, 2022

Study Registration Dates

• First Submitted: January 1, 2021
• First Submitted That Met QC Criteria: January 7, 2021
• First Posted (Actual): January 11, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 15, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: menopause; Eye disease; Macular changes
• Other Study ID Numbers: 20201987

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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