Corneal DeformityNCT05920655
Comparison of Ocular Changes by Surgical Menopause Using Optical Coherence Tomography (OCT)
An observational study of Corneal Deformity and Macular Degeneration Advanced, run by Batman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the early changes in macular thickness, corneal thickness and intraocular pressure in young women undergoing surgical menopause. Methods: Eye findings of 30 surgical menopausal (Postoperative 3-6 months) and 48 natural menopause and 22 healty women (control) were evaluated using… Read more about this study
- Who is it for?
- Ages 30 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Corneal Deformity, Macular Degeneration Advanced, Surgical Menopause
- What is being tested?
- Optic coherence tomography
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Feb 2022to 15 Jun 2023
- 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 30 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patient selection was made between surgical menopause, natural menopause and healthy women who have given birth before.
Who may be able to join
- The patients included in the study were menstruating women with preoperative natural ovarian appearance and benign non ovarian indications, who had undergone hysterectomy and bilateral salpingo-oopherectomy, and had no preoperative menopause complaints. Patients younger than 52 years of age who have undergone oophorectomy are patients whose ovaries have been removed either because of patient anxiety due to a family history of cancer or because of adhesions.
- having a healthy child
- have consented to participate in the study
Who cannot join
- Chronic disease (such as diabetes, heart disease)
- History of continuous drug use
- Unwillingness to participate in the study Being between the ages of 18-30
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Batman education adn research hospital
Batman, 72100
About this study
The aim of this study is to investigate the early changes in macular thickness, corneal thickness and intraocular pressure in young women undergoing surgical menopause.
Methods: Eye findings of 30 surgical menopausal (Postoperative 3-6 months) and 48 natural menopause and 22 healty women (control) were evaluated using OCT. Women with no known eye disease, no chronic disease (Diabetes Mellitus, Cardiac Disease any Autoimmune disease) and no migraine in addition to non smokers were included in the study. Women using any hormone and obese women ( BMI >25 kg/m2) were excluded. Macular and corneal thickness and intraocular pressure (IOP) were measured in both eyes of the women
Read the detailed description
This prospective case control study was conducted in a tertiary gynecology and obstetrics clinic and eye clinic between 2020 and 2021 with ethics committee approval number 2020 250 ). Informed consent form was obtained from all participants. All participants were outpatients who applied to obstetrics clinic in Batman Training and Research Hospital.
The study started with 105 patient. Based on the study exclusion criteria, 7 patients were excluded from the study. Every patient in the surgical menopause group underwent a hysterectomy and bilateral salpingo-oophorectomy for benign uterine reasons. The patients included in the study were menstruating women with preoperative natural ovarian appearance and benign non ovarian indications, who had undergone hysterectomy and bilateral salpingo-oophorectomy and had no preoperative menopause complaints. Patients younger than 52 years of age who have undergone oophorectomy are patients whose ovaries have been removed either because of patient anxiety due to a family history of cancer or because of adhesions.
- Being tested
- Optic coherence tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optic coherence tomographyDiagnostic test
Eye examination of patients with optic coherence tomography test by an ophthalmologist
| Study group | Role | What they receive |
|---|---|---|
| 1( Surgical menopause) | Surgical menopause : At least 6 months after hysterectomy and salphingo-oopherectomy Receives: Diagnostic Test: Optic coherence tomography | |
| 2 ( Natural menopause ) | Natural menopause :Healthy female patients who have not had a menstrual period for at least 1 year and have not received any treatment for this reason before Receives: Diagnostic Test: Optic coherence tomography | |
| 3 (Control ) | Healthy women aged 30-45 years with regular menstrual cycles and no symptoms of menopause Receives: Diagnostic Test: Optic coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of surgical menopause on corneal and macular thickness
To question the effect on macular and corneal thickness secondary to sudden ovarian hormone change with surgical menopause.
Measured: 6 months after hysterectomy and bilateral salpingo-oopherectomy
Secondary outcomes (1)
Eye examination needed after surgical menopause
To seek an answer to the question of adding eye diseases examination to the examinations of post-surgical menopause patients.
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start12 Feb 2022
- Primary completion1 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal DeformityStudies 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
- 100 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
- Investigators
- Erhan Okuyan, Principal investigator, Batman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920655
- Sponsor's protocol ID
- 2023
- Status last verified
- Jun 2023
- First submitted
- 17 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Will be given to the journal upon request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ocular Changes by Surgical Menopause Using Optical Coherence Tomography (OCT)
- ClinicalTrials.gov ID
- NCT05920655
- Acronym / sponsor ID
- 2023
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Batman Training and Research HospitalOther government
- Study start
- 12 Feb 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 27 Jun 2023 (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.
The aim of this study is to investigate the early changes in macular thickness, corneal thickness and intraocular pressure in young women undergoing surgical menopause.
Methods: Eye findings of 30 surgical menopausal (Postoperative 3-6 months) and 48 natural menopause and 22 healty women (control) were evaluated using OCT. Women with no known eye disease, no chronic disease (Diabetes Mellitus, Cardiac Disease any Autoimmune disease) and no migraine in addition to non smokers were included in the study. Women using any hormone and obese women ( BMI >25 kg/m2) were excluded. Macular and corneal thickness and intraocular pressure (IOP) were measured in both eyes of the women
Detailed description
This prospective case control study was conducted in a tertiary gynecology and obstetrics clinic and eye clinic between 2020 and 2021 with ethics committee approval number 2020 250 ). Informed consent form was obtained from all participants. All participants were outpatients who applied to obstetrics clinic in Batman Training and Research Hospital.
The study started with 105 patient. Based on the study exclusion criteria, 7 patients were excluded from the study. Every patient in the surgical menopause group underwent a hysterectomy and bilateral salpingo-oophorectomy for benign uterine reasons. The patients included in the study were menstruating women with preoperative natural ovarian appearance and benign non ovarian indications, who had undergone hysterectomy and bilateral salpingo-oophorectomy and had no preoperative menopause complaints. Patients younger than 52 years of age who have undergone oophorectomy are patients whose ovaries have been removed either because of patient anxiety due to a family history of cancer or because of adhesions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1( Surgical menopause) | – | Diagnostic Test: Optic coherence tomographySurgical menopause : At least 6 months after hysterectomy and salphingo-oopherectomy |
| 2 ( Natural menopause ) | – | Diagnostic Test: Optic coherence tomographyNatural menopause :Healthy female patients who have not had a menstrual period for at least 1 year and have not received any treatment for this reason before |
| 3 (Control ) | – | Diagnostic Test: Optic coherence tomographyHealthy women aged 30-45 years with regular menstrual cycles and no symptoms of menopause |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patient selection was made between surgical menopause, natural menopause and healthy women who have given birth before.
Key inclusion criteria (3 listed)
- The patients included in the study were menstruating women with preoperative natural ovarian appearance and benign non ovarian indications, who had undergone hysterectomy and bilateral salpingo-oopherectomy, and had no preoperative menopause complaints. Patients younger than 52 years of age who have undergone oophorectomy are patients whose ovaries have been removed either because of patient anxiety due to a family history of cancer or because of adhesions.
- having a healthy child
- have consented to participate in the study
Key exclusion criteria (3 listed)
- Chronic disease (such as diabetes, heart disease)
- History of continuous drug use
- Unwillingness to participate in the study Being between the ages of 18-30
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 |
|---|---|---|
| Optic coherence tomographyEye examination of patients with optic coherence tomography test by an ophthalmologist | Diagnostic test | 1( Surgical menopause), 2 ( Natural menopause ), 3 (Control ) |
Primary outcome
Effect of surgical menopause on corneal and macular thickness
Time frame: 6 months after hysterectomy and bilateral salpingo-oopherectomy
To question the effect on macular and corneal thickness secondary to sudden ovarian hormone change with surgical menopause.
1 secondary outcome
Eye examination needed after surgical menopause
Time frame: 6-12 months
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 27 Jun 2023.
- Individual participant dataSharing planned: Undecided. Will be given to the journal upon request.
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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.
Erhan Okuyan principal investigator
Batman Training and Research Hospital
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 Corneal Deformity and Macular Degeneration Advanced, 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 3 inclusion and 3 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 27 Jun 2023. 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?
Effect of surgical menopause on corneal and macular thickness (time frame: 6 months after hysterectomy and bilateral salpingo-oopherectomy). 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 27 Jun 2023.