- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02613442
Factors Affecting Aqueous Humor Outflow Facility in Patients With Uveitis
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.
Study Overview
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.
- Age
- Race
- Gender
- Diagnosis
- Duration of disease
- Medications, dose and duration currently and over the past year
- Visual acuity- snellen and peripheral visual fields
- Intraocular pressure
- Gonioscopy: documentation of degree of synechial angle closure
- Slit lamp examination and documentation of parameters of ocular inflammation: cells, flare, posterior synechaie extent and clock hours
- Fundus examination
Testing done solely for the study will involve:
- 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.
- 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.
Study Type
Contacts and Locations
Study Locations
-
-
Nebraska
-
Omaha, Nebraska, United States, 60198
- Truhlsen Eye Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Subjects must be 18 years or older
- Subjects have a diagnosis of uveitis
- Ability to cooperate for tonography
Exclusion Criteria:
- Any current corneal abrasion
- Hypersensitivity to proparacaine
- history of vitrectomy
- hypotony (Intraocular pressure < 5 mm Hg)
- aphakia
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in Aqeuous outflow facility
Time Frame: 9 months
|
tonographic outflow facility calculations using pneumatonography
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in intraocular pressure measured by pneumatonometer
Time Frame: 9 months during the study and previous 1 year historical eye pressure
|
pneumatonometer measurement
|
9 months during the study and previous 1 year historical eye pressure
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Deepta Ghate, MD, University of Nebraska
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0749-15-FB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Clinical Trials on Glaucoma
-
Imperial College Healthcare NHS TrustIRIDEX CorporationNot yet recruitingGlaucoma | Glaucoma, Open-Angle | Glaucoma, Angle-Closure | Glaucoma, Neovascular | Glaucoma Eye | Glaucoma Secondary | Glaucoma Traumatic | Glaucoma Uveitic
-
Wills EyeIOP OphthalmicsTerminatedPrimary Open Angle Glaucoma | Neovascular Glaucoma | Uveitic Glaucoma | Pseudoexfoliation Glaucoma | Primary Angle Closure Glaucoma | Pigmentary Glaucoma | Traumatic GlaucomaUnited States
-
Centre hospitalier de l'Université de Montréal...CompletedGlaucoma | Glaucoma, Open-Angle | Glaucoma, Neovascular | Glaucoma Eye | Glaucoma and Ocular Hypertension | Glaucoma, Uncompensated | Glaucoma SecondaryCanada
-
Pro Top & Mediking Company LimitedCompletedOpen Angle Glaucoma | Neovascular Glaucoma | Angle Closure Glaucoma | Uveitis Glaucoma | Young Age Glaucoma | High Risk PatientEstonia
-
Sanoculis LtdCompletedPrimary Open Angle Glaucoma | Pigmentary Glaucoma | Pseudoexfoliative GlaucomaIsrael
-
Bausch & Lomb IncorporatedNicOx Inc.CompletedPrimary Open Angle Glaucoma | Ocular Hypertension | Pigmentary Glaucoma | Pseudoexfoliative GlaucomaUnited States
-
Sensimed AGCompletedPrimary Open Angle Glaucoma | Pigmentary Glaucoma | Pseudoexfoliative GlaucomaFrance
-
Wills EyeOptovueCompletedPrimary Open-angle Glaucoma | Normal Tension Glaucoma | Glaucoma; DrugsUnited States
-
Ivantis, Inc.CompletedPrimary Open Angle Glaucoma | Pigmentary Glaucoma | Pseudoexfoliative GlaucomaUnited States
-
Glaucoma Research & Education GroupPharmaLogic Development, Inc.UnknownPrimary Open Angle Glaucoma | Ocular Hypertension | Pigment Dispersion Glaucoma | Pseudo-Exfoliative GlaucomaUnited States