Ocular and Vision Problems in Patients After Fontan Operation

May 3, 2022 updated by: Susan Fernandes, Stanford University
The purposes of this study are to identify indicators of vision problems and ocular abnormalities in patients with a Fontan circulation through a standardized questionnaire and to correlate the intraocular pressure measured with the Icare tonometer with central venous pressure measured with the VENUS 2000 CVP non-invasive system to determine whether intraocular pressure can be used as a surrogate measure of increased central venous pressure in patients with a Fontan circulation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Numerous authors have described optic disc edema, globe flattening, choroidal folds which were thought to be part of the well-defined but still idiopathic syndrome of idiopathic intracranial hypertension.

The pathogenesis of idiopathic intracranial hypertension is not well understood. Recent reports, however suggest that elevated cerebral venous pressure underlines the process. The close relationship that exist between spinal fluid pressure and cerebral venous pressure has been definitely established. It was found that patients with increased venous pressure due to heart failure had an increase in spinal fluid pressure as well.

Furthermore, numerous authors have described venous stasis retinopathy, bilateral choroidal detachments, intraretinal hemorrhages, vessel tortuosity, microaneurysms, capillary leakage, central retinal vein occlusion, open angle glaucoma, choroidal effusion, etc. in patients with pulmonary arterial hypertension. Elevated venous pressure found in pulmonary arterial hypertension is responsible for the delayed choroidal perfusion and the reduced venous blood outflow. This explains the clinical findings of venous stasis retinopathy, choroidal detachments, etc. which are related to elevated episcleral, retinal and choroidal venous pressure secondary to elevated systemic venous pressure (increased pulmonary vascular resistance in patients with pulmonary arterial hypertension leads to right heart failure and subsequent elevation in systemic venous pressure).

Systemic venous pressures in Fontan patients are comparable with those in patients with significant right heart failure in a 2- ventricular circulation. With Fontan anatomy the elevated central venous pressure is transmitted to the dural venous sinuses of the brain through jugular veins and the paraspinal venous plexus and after the Fontan procedure brain venous pressure are chronically elevated.

The investigators believe that the long-term effects of the Fontan operation can result in a spectrum of ocular changes similar to those occurring in patients with idiopathic intracranial and pulmonary arterial hypertensions due to chronically elevated cerebral venous pressure.

It has been reported that intraocular pressure is directly related to the episcleral and jugular venous pressure in patients without underlying ophthalmic diseases. Several previous studies have shown a linear correlation between central venous pressure and intraocular pressure. Therefore, the investigators believe that the monitoring of intraocular pressure may be simple and effective method for estimating central venous pressure in patients with Fontan circulation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford Hospital Adult Congenital Heart Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study will be conducted solely in the the Adult Congenital Heart Clinic at Stanford, and patients with congenital heart disease (CHD) will be recruited for the study.

Description

Inclusion Criteria:

  • Patients (male and female) 18 and older with Fontan circulation

Exclusion Criteria:

  • Patients under 18.
  • Patients with any prior ocular trauma or surgery.
  • Patients unwilling to consent to study.
  • Patients who are unable to speak and read English.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reported ocular medical history in Fontans
Time Frame: The final 3 months will be used for data analysis and the presentation/manuscript preparation.
Number of participants with Fontan physiology that have undergone a Fontan operation that have reported any changes in ocular and vision abnormalities by using a standardized survey.
The final 3 months will be used for data analysis and the presentation/manuscript preparation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Susan Fernandes, LPD, PA-C, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 13, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 36401

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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