Comparison of Ocular Findings in Patients Between Surgical and Natural Menopause

NCT04703231 | Completed DMC

• 1 other identifier: 20201987
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Menopause Surgical; Macula Edema; Visual Acuity Reduced Transiently

Keywords

menopause; Eye disease; Macular changes

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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

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

Interventions

measurement of macular thickness, corneal thickness and lens opacities DIAGNOSTIC_TEST

The incidence of macular thickness, Corneal thickness, intraocular pressure and lens opacities will be investigated by an ophthalmologist.

Natural menopause(Control group); Surgical Menopause (Case group)

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Batman Training and Research Hospital: lead

Study Sites (1)

Batman Maternity and Child Health Hospital

Batman, 72000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Eye Diseases

Study Design

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

Study Record Dates

• First Submitted: January 1, 2021
• First Posted: January 11, 2021
• Study Start: September 1, 2020
• Primary Completion: March 23, 2022
• Study Completion: March 23, 2022
• Last Updated: April 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)