Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID06016712

The Effect of Labor on Intraocular Pressure Fluctuation in Healthy Eyes

Led by Faculty Hospital Kralovske Vinohrady · Updated on 2025-03-19

9

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research focuses on how labor affects fluctuations in intraocular pressure, a key risk factor for glaucoma, during vaginal birth. The study involves patients with healthy eyes who either have perfect vision or a minor refractive error and regularly wear contact lenses. Researchers aim to understand the risks to glaucoma patients related to increased eye pressure during active pushing, a phase of labor not previously measured for this condition. Participants will be included between the 35th and 37th week of pregnancy, undergoing detailed eye examinations including pressure measurement before labor begins. During labor, patients will have special SENSIMED Triggerfish contact lenses placed on their eyes, which measure intraocular pressure every 5 minutes for 30 seconds, roughly matching the duration of 1 to 2 uterine contractions. Pressure will also be measured between contractions using a Tonopen device, and continuous fetal heart monitoring will occur during the second stage of labor. Throughout the study, ophthalmologists and gynecologists will collect and compare data from the contact lenses and cardiotocograph to assess how intraocular pressure changes with contractions. The lenses remain in place until two hours after birth when they are removed. Standard pregnancy check-ups continue as usual, and the study tracks both intraocular pressure fluctuations and uterine contraction rates over a 24-hour period starting with regular contractions. This allows researchers to evaluate the individual pressure changes related to labor contractions and their possible impact on glaucoma risk.

CONDITIONS

Brief Title

The Effect of Labor on Intraocular Pressure Fluctuation in Healthy Eyes

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Physiological pregnancy
  • Primiparous women
Not Eligible

You will not qualify if you...

  • Multiparous women
  • Pathological pregnancy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for detailed eye examination including intraocular pressure measurement

Treatment

Duration - From start of regular contractions through at least 2 hours after delivery (up to 24 hours)

Participants wear SENSIMED Triggerfish contact lenses to measure intraocular pressure during labor, with continuous cardiotocograph monitoring during the second stage of labor.

1 visit at labor onset (in-person) and lens removal approximately 2 hours after delivery

Trial Site Locations

Total: 1 location

1

Faculty Hospital Kralovske Vinohrady

Prague, Czechia, 11000

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Research Team

J

Jan Zapletal, MD

A

Alina Dana Baxant, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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