The Effect of Labor on Intraocular Pressure Fluctuation in Healthy Eyes

Intraocular Pressure Clinical Trial

— ELIPFHE  

Official title:

The Effect of Labor on Intraocular Pressure Fluctuation in Healthy Eyes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06016712
• Other study ID #: EK-VP/55l012022
• Secondary ID: Internal hospita
• Status: Recruiting
• Phase: N/A
• Start date: August 8, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Faculty Hospital Kralovske Vinohrady
• Contact: Jan Zapletal, MD
• Phone: +420607882602
• Email: honza.zaple[@]seznam.cz
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• physiological pregnancy

• primiparous women

Exclusion Criteria:

• multiparous women

• pathological pregnancy

Related Conditions & MeSH terms

• Delivery
• Intraocular Pressure

Intervention

Device:
• SENSIMED Triggerfish Eye Lenses
Contact lenses used for measuring intraocular pressure.

Locations

Country	Name	City	State
Czechia	Faculty Hospital Kralovske Vinohrady	Praha

Sponsors (1)

Lead Sponsor	Collaborator
Faculty Hospital Kralovske Vinohrady

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fluctuation of Intraocular pressure	Investigators will use SENSIMED Triggerfish Lenses - contact lenses used for measuring intraocular pressure. Lenses are sending detailed description of intraocular pressure in regular time range. Measurements are then send to the software which compares all collected data.	From start of regular contractions for the length of 24 hours (at least 2 hours after delivery if patient complies about the lenses)
Primary	Rate of Uterine contractions	Cardiotocography will be used for measuring regular uterine activity. Tocography will be used for evaluation of uterine activity compared to intraocular pressure	Continuous CTG will be done during II phase of delivery and at least every 2 hours durins I phase of delivery