Comparison of Ocular Findings in Patients Between Surgical and Natural Menopause

Sponsor

Batman Maternity and Child's Health Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04703231

Collaborator

(none)

Enrollment

Location

18.7

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Menopause Surgical Macula Edema Visual Acuity Reduced Transiently	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 Design

Study Type:

Observational

Actual Enrollment :

60 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Comparison of Ocular Findings in Patients Between Surgical and Natural Menopause

Actual Study Start Date :

Sep 1, 2020

Actual Primary Completion Date :

Mar 23, 2022

Actual Study Completion Date :

Mar 23, 2022

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Batman Maternity and Child Health Hospital	Batman		Turkey	72000

Sponsors and Collaborators

Batman Maternity and Child's Health Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Erhan Okuyan,M.D, Principle investigator, Batman Maternity and Child's Health Hospital

ClinicalTrials.gov Identifier:

NCT04703231

Other Study ID Numbers:

20201987

First Posted:

Jan 11, 2021

Last Update Posted:

Apr 18, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Erhan Okuyan,M.D, Principle investigator, Batman Maternity and Child's Health Hospital

menopause

Eye disease

Macular changes

Study Results

No Results Posted as of Apr 18, 2022