Comparison of Ocular Findings in Patien… | Clinical Trial

Key information

Conditions

Menopause Surgical Eye Diseases Macula Edema Visual Acuity Reduced Transiently

Age range

45 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Batman Maternity and Child Health Hospital

Batman, 72000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Macular thickness measurement

Time frame: 3 months after menopause

Macular thickness(micron) in both eyes will be measured by optical coherence tomography,
Detecting lens opacities

Time frame: 3 months after menopause

Lens opacities (Grade 1,2,3,4) will be measured by indirect biomicroscopy,
Intraocular pressure measurement

Time frame: 3 months after menopause

Intraocular pressures( mm Hg) will be measured and recorded with the applanation tonometry device.
Comparison of all detected data

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Batman Training and Research Hospital

Other Gov

Registry information

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: Jan 11, 2021
Registry last updated: Apr 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed