Menopause SurgicalNCT04703231
Comparison of Ocular Findings in Patients Between Surgical and Natural Menopause
An observational study of Menopause Surgical and Macula Edema, run by Batman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
It is aimed to compare the ocular findings in patients with natural and surgical menopause. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Menopause Surgical, Macula Edema, Visual Acuity Reduced Transiently
- What is being tested?
- measurement of macular thickness, corneal thickness and lens opacities
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 23 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Will be studied in a patient population with low sociocultural level.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Batman Maternity and Child Health Hospital
Batman, 72000
About this study
It is aimed to compare the ocular findings in patients with natural and surgical menopause.
Read the 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.
- Being tested
- measurement of macular thickness, corneal thickness and lens opacities
- Keywords
- menopause, Eye disease, Macular changes
- Medical subject headings
- Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of macular thickness, corneal thickness and lens opacitiesDiagnostic test
The incidence of macular thickness, Corneal thickness, intraocular pressure and lens opacities will be investigated by an ophthalmologist.
| Study group | Role | What they receive |
|---|---|---|
| Natural menopause(Control group) | Female patients between 45-60 years of age diagnosed with menopause without any intervention Receives: 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 Receives: Diagnostic Test: measurement of macular thickness, corneal thickness and lens opacities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macular thickness measurement
Macular thickness(micron) in both eyes will be measured by optical coherence tomography,
Measured: 3 months after menopause
Detecting lens opacities
Lens opacities (Grade 1,2,3,4) will be measured by indirect biomicroscopy,
Measured: 3 months after menopause
Intraocular pressure measurement
Intraocular pressures( mm Hg) will be measured and recorded with the applanation tonometry device.
Measured: 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.
Measured: 3 months after menopause
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start1 Sep 2020
- Primary completion23 Mar 2022
- Study completion23 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopause SurgicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batman Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Erhan Okuyan,M.D, Batman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04703231
- Sponsor's protocol ID
- 20201987
- Status last verified
- Apr 2022
- First submitted
- 1 Jan 2021
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ocular Findings in Patients Between Surgical and Natural Menopause
- ClinicalTrials.gov ID
- NCT04703231
- Acronym / sponsor ID
- 20201987
- Keywords
- menopause, Eye disease, Macular changes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Batman Training and Research HospitalOther government
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 23 Mar 2022 (actual)
- Study completion
- 23 Mar 2022 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Natural menopause(Control group) | – | Diagnostic Test: measurement of macular thickness, corneal thickness and lens opacitiesFemale patients between 45-60 years of age diagnosed with menopause without any intervention |
| Surgical Menopause (Case group) | – | Diagnostic Test: measurement of macular thickness, corneal thickness and lens opacitiesFemale patients aged 45-60 years included in the study 3 months after bilateral oophorectomy and hysterectomy |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Will be studied in a patient population with low sociocultural level.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- Smoking or Alchohol consumption
- Age before 45 and after 65 years
- Have chronic disease
- Using any medication
- Have not diagnosed Menopause
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurement of macular thickness, corneal thickness and lens opacitiesThe incidence of macular thickness, Corneal thickness, intraocular pressure and lens opacities will be investigated by an ophthalmologist. | Diagnostic test | Natural menopause(Control group), Surgical Menopause (Case group) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause Surgical and Macula Edema, run by Batman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macular thickness measurement (time frame: 3 months after menopause). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.