Corneal DystrophyNCT05927740
The Efficacy of Hyperemesis Gravidarum on Macular Thickness, Corneal Thickness and Intraocular Pressure in Pregnancy
A study testing Optic coherence tomography in people with Corneal Dystrophy and Macular Dystrophy, run by Batman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Aim Physiological changes in intraocular pressure as well as in the cornea and macula may occur during pregnancy. In the literature, there are limited data on ocular findings in hyperemesis gravidarum. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Corneal Dystrophy, Macular Dystrophy, Hyperemesis Gravidarum - Severe
- What is being tested?
- Optic coherence tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Mar 2020to 11 May 2023
- Phase
- Interventional
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- First trimester (8-14 weeks of gestation) pregnancy with positive fetal heartbeat and no history of systemic disease ,
- no history of continuous drug use,
- Diagnosis of hyperemesis gravidarum (ketonuria and weight >3 kg or 5% of the body) The occurrence of >3 vomiting attacks per day with loss of weight,
- Body mass index (BMI) within normal limits,
- Being between the ages of 18-40 ,
- not drinking alcohol or smoking,
- not using any vitamins or supplements use during the study
Who cannot join
- Any patient who did not meet the inclusion criteria was excluded from the study.
- Patients who participated in the study but later gave up
Trial locations and contacts
1 site in 1 country.
About this study
Aim
Physiological changes in intraocular pressure as well as in the cornea and macula may occur during pregnancy.
In the literature, there are limited data on ocular findings in hyperemesis gravidarum. Therefore, we have decided to investigate the effect of hyperemesis gravidarum on macular thickness, corneal thickness and intraocular pressure (IOP).
Read the detailed description
A total of 110 people, 55 of whom were diagnosed with hyperemesis gravidarum and 55 of whom were in the control group, were included in the study. The inclusion criteria for the study were as follows: First trimester (8-14 weeks of gestation) pregnancy with positive fetal heartbeat and no history of systemic disease; no continuous use of medication; diagnosis of hyperemesis gravidarum (ketonuria and weight > 3 kg or 5% of the body) and the occurrence of less than three vomiting attacks per day with loss of weight; body mass index (BMI) within normal limits; being between the ages of 18 and 40; not drinking alcohol or smoking. A total of 94 patients, 40 of whom were diagnosed with hyperemesis gravidarum and 54 healthy pregnant women, were divided into two groups by recording their age, BMI, laboratory and eye findings.
- Being tested
- Optic coherence tomography
- Medical subject headings
- Corneal Dystrophies, Hereditary, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optic coherence tomographyDiagnostic test
Every participant was subjected to a comprehensive ophthalmologic examination which included measuring auto-refraction (average of three values, Topcon Autorefractometer model KM 8900, Japan), uncorrected visual acuity with cycloplegic refraction (with 0.5% cyclopentolate HCl), and IOP in millimeters of mercury (mmHg, Goldmann applanation tonometer). Moreover, slit-lamp biomicroscopy (HaagStreit, Bern, Switzerland) was performed, concentrating on potential corneal scarring and/or lenticular opacities.
| Study group | Role | What they receive |
|---|---|---|
| 1 ( Hyperemesis gravidarum ) | Other | 55 hyperemesis gravidarum patient (11-14th gestational week of pregnancy) Receives: Diagnostic Test: Optic coherence tomography |
| 2( Control group) | Other | 55 healthy pregnant women (11-14th gestational week of pregnancy) Receives: Diagnostic Test: Optic coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Take precautions of the effect of hyperemesis gravidarum on eye health
The first-line treatment of Hyperemesis gravidarum (HG) patients ( 6 -14 th weeks of pregnant women ) is fluid depletion and antiemetic therapy, but in severe HG, sepsis, thrombosis secondary to parenteral nutrition, and, albeit rare, Wernicke's encephalopathy (WE). This condition (WE), which is defined as a sign of optic disc swelling that causes a diagnostic dilemma in pregnancy, can be diagnosed with a high index of suspicion by clinical signs and radiological evidence, and generally, patients experience rapid improvement in clinical symptoms with intravenous thiamine therapy. For all this reason, it is extremely important to take necessary precautions for obstetricians. Our primary outcome is to compare the macular thickness and corneal thickness of HG patients participating in the study with normal healthy pregnant women using Optic coherancetomography.
Measured: Healthy pregnant women and pregnant women diagnosed with Hyperemesis gravidarum between 6-14 weeks; eye examination findings were immediately recorded in the system. (within 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start10 Mar 2020
- Primary completion13 Feb 2022
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal DystrophyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups ( group 1 hyperemesis gravidarum ) (group 2 control group)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 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
- NCT05927740
- Sponsor's protocol ID
- 2020-5
- Status last verified
- Jun 2023
- First submitted
- 17 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Available for the journal administrator
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Hyperemesis Gravidarum on Macular Thickness, Corneal Thickness and Intraocular Pressure in Pregnancy
- ClinicalTrials.gov ID
- NCT05927740
- Acronym / sponsor ID
- 2020-5
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Batman Training and Research HospitalOther government
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 13 Feb 2022 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 3 Jul 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.
Aim
Physiological changes in intraocular pressure as well as in the cornea and macula may occur during pregnancy.
In the literature, there are limited data on ocular findings in hyperemesis gravidarum. Therefore, we have decided to investigate the effect of hyperemesis gravidarum on macular thickness, corneal thickness and intraocular pressure (IOP).
Detailed description
A total of 110 people, 55 of whom were diagnosed with hyperemesis gravidarum and 55 of whom were in the control group, were included in the study. The inclusion criteria for the study were as follows: First trimester (8-14 weeks of gestation) pregnancy with positive fetal heartbeat and no history of systemic disease; no continuous use of medication; diagnosis of hyperemesis gravidarum (ketonuria and weight > 3 kg or 5% of the body) and the occurrence of less than three vomiting attacks per day with loss of weight; body mass index (BMI) within normal limits; being between the ages of 18 and 40; not drinking alcohol or smoking. A total of 94 patients, 40 of whom were diagnosed with hyperemesis gravidarum and 54 healthy pregnant women, were divided into two groups by recording their age, BMI, laboratory and eye findings.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 groups ( group 1 hyperemesis gravidarum ) (group 2 control group)
| Arm | Type | Receives |
|---|---|---|
| 1 ( Hyperemesis gravidarum ) | Other | Diagnostic Test: Optic coherence tomography55 hyperemesis gravidarum patient (11-14th gestational week of pregnancy) |
| 2( Control group) | Other | Diagnostic Test: Optic coherence tomography55 healthy pregnant women (11-14th gestational week of pregnancy) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
Key exclusion criteria (2 listed)
- Any patient who did not meet the inclusion criteria was excluded from the study.
- Patients who participated in the study but later gave up
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 tomographyEvery participant was subjected to a comprehensive ophthalmologic examination which included measuring auto-refraction (average of three values, Topcon Autorefractometer model KM 8900, Japan), uncorrected visual acuity with cycloplegic refraction (with 0.5% cyclopentolate HCl), and IOP in millimeters of mercury (mmHg, Goldmann applanation tonometer). Moreover, slit-lamp biomicroscopy (HaagStreit, Bern, Switzerland) was performed, concentrating on potential corneal scarring and/or lenticular opacities. | Diagnostic test | 1 ( Hyperemesis gravidarum ), 2( Control group) |
Primary outcome
Take precautions of the effect of hyperemesis gravidarum on eye health
Time frame: Healthy pregnant women and pregnant women diagnosed with Hyperemesis gravidarum between 6-14 weeks; eye examination findings were immediately recorded in the system. (within 1 day)
The first-line treatment of Hyperemesis gravidarum (HG) patients ( 6 -14 th weeks of pregnant women ) is fluid depletion and antiemetic therapy, but in severe HG, sepsis, thrombosis secondary to parenteral nutrition, and, albeit rare, Wernicke's encephalopathy (WE). This condition (WE), which is defined as a sign of optic disc swelling that causes a diagnostic dilemma in pregnancy, can be diagnosed with a high index of suspicion by clinical signs and radiological evidence, and generally, patients experience rapid improvement in clinical symptoms with intravenous thiamine therapy. For all this reason, it is extremely important to take necessary precautions for obstetricians. Our primary outcome is to compare the macular thickness and corneal thickness of HG patients participating in the study with normal healthy pregnant women using Optic coherancetomography.
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 3 Jul 2023.
- Individual participant dataSharing planned: Undecided. Available for the journal administrator
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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?
A study testing Optic coherence tomography in people with Corneal Dystrophy and Macular Dystrophy, 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 2 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 3 Jul 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?
Take precautions of the effect of hyperemesis gravidarum on eye health (time frame: Healthy pregnant women and pregnant women diagnosed with Hyperemesis gravidarum between 6-14 weeks; eye examination findings were immediately recorded in the system. (within 1 day)). 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 3 Jul 2023.