Factors Affecting Aqueous Humor Outflow Facility in Patients With Uveitis

Glaucoma Clinical Trial

Official title:

Factors Affecting Aqueous Humor Outflow Facility in Patients With Uveitis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02613442
• Other study ID #: 0749-15-FB
• Status: Withdrawn
• Start date: April 2017
• Est. completion date: April 13, 2017

Study information

• Verified date: August 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 13, 2017
• Est. primary completion date: April 13, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• UVeitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Aqeuous outflow facility	tonographic outflow facility calculations using pneumatonography	9 months
Secondary	change in intraocular pressure measured by pneumatonometer	pneumatonometer measurement	9 months during the study and previous 1 year historical eye pressure