The Effect of Labor on Intraocular Pressure Fluctuation in Healthy Eyes

NCT ID: NCT06016712

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-08
• Study Completion Date: 2025-12-31

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.

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.

Conditions

Intraocular Pressure; Delivery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participant

SENSIMED Triggerfish lenses will be applied on this Arm and Intraocular pressure during active phase of delivery will be measured

Group Type: EXPERIMENTAL

SENSIMED Triggerfish Eye Lenses

Intervention Type: DEVICE

Contact lenses used for measuring intraocular pressure.

Interventions

SENSIMED Triggerfish Eye Lenses

Contact lenses used for measuring intraocular pressure.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• physiological pregnancy
• primiparous women

Exclusion Criteria

• multiparous women
• pathological pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Faculty Hospital Kralovske Vinohrady

OTHER_GOV

Sponsor Role: lead

Responsible Party

Jan Zapletal

Medical Doctor, Department of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pavel Studeny, prof, MD, Ph.D.

Role: STUDY_CHAIR

Fakultni Nemocnice Kralovske Vinohrady

Locations

Faculty Hospital Kralovske Vinohrady

Prague, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Jan Zapletal, MD

Role: CONTACT

honza.zaple@seznam.cz

+420607882602

Alina Dana Baxant, MD

Role: CONTACT

alinadana.baxant@fnkv.cz

+420734395155

Facility Contacts

Jan Zapletal, MD

Role: primary

honza.zaple@seznam.cz

+420607882602

Other Identifiers

Internal hospital grant

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

EK-VP/55l012022

Identifier Type: -

Identifier Source: org_study_id