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Completed Not applicable Interventional Results available

Twenty-four Hour Intraocular Pressure Patterns in Patients With Uncontrolled Thyroid Eye Disease

ClinicalTrials.gov ID: NCT01798966

Public ClinicalTrials.gov record NCT01798966. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 3:45 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

The Effects of Orbital Decompression Surgery on Intraocular Pressure Patterns in Patient With Thyroid Eye Disease Undergoing 24 Hour Continuous IOP Monitoring With the SENSIMED Triggerfish®

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Patients with Thyroid Eye Disease (TED) often have enlarged extraocular muscles and higher orbital fat contents due to their disease process. The confined space of the orbit cannot hold the enlarged orbital contents creating a forward displacement and/or compression of the globe with a rise in intraocular pressure (IOP). Many of these patients undergo surgical decompression, a procedure that fractures orbital bones, in order to allow more space for the enlarged orbital contents to occupy. To date, there is no data that shows intraocular patterns over a 24-hour period in patients with mechanical compression on the globe as in TED. It is not know if the pattern of IOP is more consistent with normal IOP patterns, glaucomatous patterns, or perhaps completely different then either. The goal of this project is to investigate patterns of IOP in patients requiring orbital decompression because of orbital congestion. Changes in IOP during a 24-hour period will be studied with a contact-lens embedded sensor that provides continuous data. This device has previously been investigated and shown to be safe and well-tolerated. Monitoring the pattern in these patients will allow us to compare Thyroid TED patterns of IOP with those of normal and glaucomatous patients. Also, testing these patients before and after orbital decompression surgery will allow characterization of how intraocular pressure changes once the mechanical compression on the globe is relieved.

Study identification

NCT ID
NCT01798966
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
Sensimed AG
Industry
Enrollment
10 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
18 Years to 90 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 31, 2013
Primary completion
May 31, 2013
Completion
May 31, 2013
Last update posted
Mar 10, 2016

2013

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Shiley Eye Center, University of California, San Diego La Jolla California 92093-0496

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01798966, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 10, 2016 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01798966 live on ClinicalTrials.gov.

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