Comparison of Ocular Findings in Patients Between Surgical and Natural Menopause

Completed

• Conditions: Macula Edema; Visual Acuity Reduced Transiently; Menopause Surgical
• Interventions: Diagnostic Test: measurement of macular thickness, corneal thickness and lens opacities

• Registration Number: NCT04703231
• Lead Sponsor: Batman Training and Research Hospital

Brief Summary

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

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 Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2021-01-01
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-11
• Primary Completion: 2022-03-23
• Study Completion: 2022-03-23
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-15
• Last Update Posted: 2022-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Natural menopause(Control group)	measurement of macular thickness, corneal thickness and lens opacities	Female patients between 45-60 years of age diagnosed with menopause without any intervention
Surgical Menopause (Case group)	measurement of macular thickness, corneal thickness and lens opacities	Female patients aged 45-60 years included in the study 3 months after bilateral oophorectomy and hysterectomy

Primary Outcome Measures

Name	Time	Method
Macular thickness measurement	3 months after menopause	Macular thickness(micron) in both eyes will be measured by optical coherence tomography,
Detecting lens opacities	3 months after menopause	Lens opacities (Grade 1,2,3,4) will be measured by indirect biomicroscopy,
Intraocular pressure measurement	3 months after menopause	Intraocular pressures( mm Hg) will be measured and recorded with the applanation tonometry device.
Comparison of all detected data	3 months after menopause	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.

Trial Locations

Locations (1)

Batman Maternity and Child Health Hospital; 🇹🇷 Batman, Turkey