The Effect of Labor on Intraocular Pressure Fluctuation in Healthy Eyes

NCT06016712 | Recruiting

• 2 other identifiers: EK-VP/55l012022Internal hospital grant
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Intraocular Pressure; Delivery

Keywords

Intraocular pressure; delivery; pregnancy; glaucoma

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Participant

EXPERIMENTAL

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

Interventions

SENSIMED Triggerfish Eye Lenses DEVICE

Contact lenses used for measuring intraocular pressure.

Participant

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• physiological pregnancy
• primiparous women

You may not qualify if:

• multiparous women
• pathological pregnancy

Sponsors & Collaborators

• Faculty Hospital Kralovske Vinohrady: lead

Study Sites (1)

Faculty Hospital Kralovske Vinohrady

Prague, 11000, Czechia

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Pavel Studeny, prof, MD, Ph.D.

  Fakultni Nemocnice Kralovske Vinohrady

  STUDY CHAIR

Central Study Contacts

Jan Zapletal, MD

CONTACT

+420607882602; honza.zaple@seznam.cz

Alina Dana Baxant, MD

CONTACT

+420734395155; alinadana.baxant@fnkv.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 30, 2023
• Study Start: August 8, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)