Comparison of Ocular Findings in Patients Between Surgical and Natural Menopause

Macula Edema Clinical Trial

Official title:

Comparison of Ocular Findings in Patients Between Surgical and Natural Menopause

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04703231
• Other study ID #: 20201987
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: March 23, 2022

Study information

• Verified date: April 2022
• Source: Batman Maternity and Child's Health Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 23, 2022
• Est. primary completion date: March 23, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Macula Edema
• Menopause Surgical
• Visual Acuity Reduced Transiently

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.

Locations

Country	Name	City	State
Turkey	Batman Maternity and Child Health Hospital	Batman

Sponsors (1)

Lead Sponsor	Collaborator
Batman Maternity and Child's Health Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Macular thickness measurement	Macular thickness(micron) in both eyes will be measured by optical coherence tomography,	3 months after menopause
Primary	Detecting lens opacities	Lens opacities (Grade 1,2,3,4) will be measured by indirect biomicroscopy,	3 months after menopause
Primary	Intraocular pressure measurement	Intraocular pressures( mm Hg) will be measured and recorded with the applanation tonometry device.	3 months after menopause
Primary	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