Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 3490 for:    Facility

Factors Affecting Aqueous Humor Outflow Facility in Patients With Uveitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02613442
Recruitment Status : Withdrawn (Due to uveitis specialist leaving our University)
First Posted : November 24, 2015
Last Update Posted : September 26, 2017
Sponsor:
Information provided by (Responsible Party):
Deepta Ghate MD, University of Nebraska

Brief Summary:

Objective: To determine the clinical variables that influence aqueous outflow facility (Co) and intraocular pressure (IOP) in uveitis.

Uveitic glaucoma is potentially blinding and occurs in 17-46% of chronic uveitis patients. Uveitic activity causes fluctuating IOP due to decreased Co, increased uveoscleral outflow or decreased aqueous production.

Specific Aim 1: To evaluate the risk factors for high IOP and low Co in uveitis Hypothesis: Decreased Co and increased IOP will occur with increasing anterior chamber (AC) flare, AC cells, degree of synechial angle closure, increased duration of disease, higher uveitis activity and increasing steroid use Specific Aim 2: To determine prospectively the effect of AC flare on Co and IOP in "quiescent" uveitis Hypothesis: AC flare even in the absence of AC cells will cause progressive decline in Co.

Methods: In this proof of concept study, thirty consecutive patients with acute or chronic uveitis will be recruited from the uveitis clinic. Ten patients with "quiescent" uveitis (no AC cells) will be recruited for the prospective arm and followed every 2-3 months for 3 visits. Co will be measured using 2-minute pneumatonometer tonography. The effect of risk factors on IOP and Co in uveitis will be studied using generalized linear modelling techniques. These risk factors include AC flare (using the laser flare meter), AC cells, degree of angle closure (by gonioscopy), duration of disease, disease activity and corticosteroid use within the last year. In the prospective study, the patients will be divided into subgroups with low flare (< 20ph/ms) and high flare (≥ 20 ph/msec) and the change in Co and IOP will be analyzed.

Impact: This will be the first study to systematically analyze the risk factors for decrease in Co and increase in IOP in uveitis and to prospectively evaluate the effect of AC flare on Co. Proof that AC flare can damage the trabecular meshwork will corroborate previous experimental evidence and change the paradigm of uveitis treatment. Knowledge of the risk factors that affect Co and IOP will aid in identifying patients that may need escalation of their uveitis or glaucoma treatment to prevent optic nerve damage.


Condition or disease
UVeitis Glaucoma

Detailed Description:

Prospective subjects will be identified from the patient population pool in the Uveitis Clinic at the Truhlsen Eye Institute, University of Nebraska Medical Center, Department of Ophthalmology and Visual Sciences.

The procedures below will be performed at the first visit in all patients and at the patient's return visit in the 10 patients recruited for the prospective arm of the study (upto a maximum of 3 follow up visits)

The following information will be extracted from the chart. These are obtained routinely as part of routine clinical care through history and ocular examination by slit lamp examination and applanation tonometry for intraocular pressure measurements.

  1. Age
  2. Race
  3. Gender
  4. Diagnosis
  5. Duration of disease
  6. Medications, dose and duration currently and over the past year
  7. Visual acuity- snellen and peripheral visual fields
  8. Intraocular pressure
  9. Gonioscopy: documentation of degree of synechial angle closure
  10. Slit lamp examination and documentation of parameters of ocular inflammation: cells, flare, posterior synechaie extent and clock hours
  11. Fundus examination

Testing done solely for the study will involve:

  1. Tonographic Outflow facility: will be assessed using the pneumatonography. A two (2) minute tonography protocol will be used. The subject will be in a supine position as the weighted pneumatonometer probe is placed on the eye measuring aqueous outflow. The patient may need another drop of proparacaine prior to the test if the previous anesthesia is insufficient. This procedure should take 3-4 minutes.
  2. Aqueous flare meter: The anterior chamber flare will be measured in a non-invasive way using the AC flare meter. This process will take 2-3 minutes and does not require any additional topical anesthesia.

Layout table for study information
Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Factors Affecting Aqueous Humor Outflow Facility in Patients With Uveitis
Estimated Study Start Date : April 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. change in Aqeuous outflow facility [ Time Frame: 9 months ]
    tonographic outflow facility calculations using pneumatonography


Secondary Outcome Measures :
  1. change in intraocular pressure measured by pneumatonometer [ Time Frame: 9 months during the study and previous 1 year historical eye pressure ]
    pneumatonometer measurement



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prospective subjects will be identified from the patient population pool in the Uveitis Clinic at the Truhlsen Eye Institute, University of Nebraska Medical Center, Department of Ophthalmology and Visual Sciences.
Criteria

Inclusion Criteria:

  1. Subjects must be 18 years or older
  2. Subjects have a diagnosis of uveitis
  3. Ability to cooperate for tonography

Exclusion Criteria:

  1. Any current corneal abrasion
  2. Hypersensitivity to proparacaine
  3. history of vitrectomy
  4. hypotony (Intraocular pressure < 5 mm Hg)
  5. aphakia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02613442


Locations
Layout table for location information
United States, Nebraska
Truhlsen Eye Institute
Omaha, Nebraska, United States, 60198
Sponsors and Collaborators
University of Nebraska
Investigators
Layout table for investigator information
Principal Investigator: Deepta Ghate, MD University of Nebraska

Layout table for additonal information
Responsible Party: Deepta Ghate MD, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT02613442     History of Changes
Other Study ID Numbers: IRB # 749-15-FB
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: September 26, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Plan would need to be approved by IRB prior to publication here.
Additional relevant MeSH terms:
Layout table for MeSH terms
Uveitis
Eye Diseases
Uveal Diseases