The Effect of Labor on Intraocular Pressure Fluctuation in Healthy Eyes (ELIPFHE)

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.

Study Overview

• Status: Recruiting
• Conditions: Intraocular Pressure; Delivery
• Intervention / Treatment: Device: SENSIMED Triggerfish Eye Lenses

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 9
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan Zapletal, MD; Phone Number: +420607882602; Email: honza.zaple@seznam.cz
• Study Contact Backup: Name: Alina Dana Baxant, MD; Phone Number: +420734395155; Email: alinadana.baxant@fnkv.cz

Study Locations

• Czechia
  • Praha, Czechia, 11000
    • Recruiting
    • Faculty Hospital Kralovske Vinohrady
    • Contact: Jan Zapletal, MD; Phone Number: +420607882602; Email: honza.zaple@seznam.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• physiological pregnancy
• primiparous women

Exclusion Criteria:

• multiparous women
• pathological pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participant; SENSIMED Triggerfish lenses will be applied on this Arm and Intraocular pressure during active phase of delivery will be measured	Device: SENSIMED Triggerfish Eye Lenses; Contact lenses used for measuring intraocular pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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

Collaborators and Investigators

• Sponsor: Faculty Hospital Kralovske Vinohrady
• Investigators: Study Chair: Pavel Studeny, prof, MD, Ph.D., Fakultni nemocnice Kralovske Vinohrady

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 8, 2023
• First Submitted That Met QC Criteria: August 23, 2023
• First Posted (Actual): August 30, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 16, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Intraocular pressure; pregnancy; delivery; glaucoma
• Other Study ID Numbers: EK-VP/55l012022; Internal hospital grant (Other Grant/Funding Number: Fakultni Nemocnice Kralovske Vinohrady)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No