Factors Affecting Aqueous Humor Outflow Facility in Patients with Uveitis

NCT02613442 | Withdrawn

• 1 other identifier: 0749-15-FB
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

UVeitis; Glaucoma

Outcome Measures

Primary Outcomes (1)

• change in Aqeuous outflow facility

  tonographic outflow facility calculations using pneumatonography

  9 months

Secondary Outcomes (1)

• change in intraocular pressure measured by pneumatonometer

  9 months during the study and previous 1 year historical eye pressure

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subjects must be 18 years or older
• Subjects have a diagnosis of uveitis
• Ability to cooperate for tonography

You may not qualify if:

• Any current corneal abrasion
• Hypersensitivity to proparacaine
• history of vitrectomy
• hypotony (Intraocular pressure \< 5 mm Hg)
• aphakia

Sponsors & Collaborators

• University of Nebraska: lead

MeSH Terms

Conditions

Uveitis; Glaucoma

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Ocular Hypertension

Study Officials

• Deepta Ghate, MD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: November 24, 2015
• Study Start: April 13, 2017
• Primary Completion: April 13, 2017
• Study Completion: April 13, 2017
• Last Updated: September 3, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share