Ocular and Vision Problems in Patients After Fontan Operation

NCT03170778 | Completed DMC

• 1 other identifier: 36401
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Heart Disease

Keywords

Congenital Heart Disease; CHD; Fontan

Outcome Measures

Primary Outcomes (1)

• Reported ocular medical history in Fontans

  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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital Adult Congenital Heart Clinic

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Susan Fernandes, LPD, PA-C

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Pediatrics - Cardiology Clinical Professor, Medicine - Cardiovascular Medicine

Study Record Dates

• First Submitted: April 26, 2017
• First Posted: May 31, 2017
• Study Start: February 13, 2016
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: May 4, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)