NCT06016712 The Effect of Labor on Intraocular Pressure Fluctuation in Healthy Eyes
| NCT ID | NCT06016712 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Faculty Hospital Kralovske Vinohrady |
| Condition | Intraocular Pressure |
| Study Type | INTERVENTIONAL |
| Enrollment | 9 participants |
| Start Date | 2023-08-08 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 9 participants in total. It began in 2023-08-08 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Glaucoma is a multifactorial disease, an important risk factor of which is increased intraocular pressure. Fluctuations in intraocular pressure are often associated with vaginal birth, although intraocular pressure during active pushing during stage II has never been measured.. The study will be conducted on a group of patients with healthy eyes on patients who have completely fine vision or have a small refractive error and are accustomed to wearing contact lenses. The measurement of intraocular pressure itself will be carried out using SENSIMED Triggerfish contact lenses, which measure pressure every 5 minutes for 30s. This period roughly corresponds to the duration of 1-2 contractions. Inclusion in the study will be offered to patients in the 35th to 37th week of pregnancy. Prior to measurement patients will be sent to an eye clinic for a detailed examination of both eyes, which includes measuring intraocular pressure. Subsequently, pregnancy checks will take place according to the standard scheme and in the standard scope. At the onset of uterine contractions, an ophthalmologic consultant will be called, which will measure intraocular pressure between contractions using the Tonopen device and put on SENSIMED Trigerfish contact lenses in combination with a local anesthetic. The patient will have these lenses until the end of the third stage of labor, i.e. 2 hours after the birth, when the lenses are removed. In the second stage of labor, continuous monitoring by a cardiotocograph will take place. Subsequently, the obtained data from the cardiotocograph and contact lenses will be evaluated and compared by a team of ophthalmologists and gynecologists, where the investigators will be able to assess the individual fluctuations in intraocular pressure depending on the individual contractions. The aim of the study is to demonstrate or disprove the risks to the glaucoma patient due to increased intraocular pressure during active pushing in combination with uterine contraction.
Eligibility Criteria
Inclusion Criteria: * physiological pregnancy * primiparous women Exclusion Criteria: * multiparous women * pathological pregnancy
Contact & Investigator
Pavel Studeny, prof, MD, Ph.D.
STUDY CHAIR
Fakultni Nemocnice Kralovske Vinohrady
Frequently Asked Questions
Who can join the NCT06016712 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Intraocular Pressure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06016712 currently recruiting?
Yes, NCT06016712 is actively recruiting participants. Contact the research team at honza.zaple@seznam.cz for enrollment information.
Where is the NCT06016712 trial being conducted?
This trial is being conducted at Prague, Czechia.
Who is sponsoring the NCT06016712 clinical trial?
NCT06016712 is sponsored by Faculty Hospital Kralovske Vinohrady. The principal investigator is Pavel Studeny, prof, MD, Ph.D. at Fakultni Nemocnice Kralovske Vinohrady. The trial plans to enroll 9 participants.