Aqueous Humor Dynamics and Hypertensive Uveitis

NCT02765308 | Completed

• 1 other identifier: 136787
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

Uveitis is a disease that affects over 2 million people around the globe, and can ultimately lead to blindness. The proportion of patients with uveitis who become blind has not been reduced over the past 30 years, and this is therefore an area that demands further research. One of the major causes of blindness in uveitic patients is the development of uveitic glaucoma, which occurs in 10-20% of uveitic eyes. This is likely to occur for reasons related to the uveitis itself, but can also be caused as a side effect of the corticosteroids used to treat uveitis. The raised IOP in uveitis is more difficult to treat than other types of glaucoma. To enable more effective treatment of uveitic glaucoma, the investigators need to understand more clearly the mechanisms which underlie this process. The investigators therefore propose a study to examine the contribution of altered aqueous dynamics to the development of raised IOP in uveitis.

Conditions

Uveitic Glaucoma; Anterior Uveitis

Keywords

Uveitis; Glaucoma; Aqueous humor dynamics

Outcome Measures

Primary Outcomes (2)

• Facility of outflow

  Tonographic outflow facility (C) will be performed using an electronic Schiøtz tonographer (Model 720, Berkeley Bioengineering Inc, USA) at 10AM

  day 1 only (study completion)

• Rate of aqueous flow (measured by fluorophotometry).

  Fluorophotometry will be performed in both eyes using a scanning ocular fluorophotometer from 9AM to 12PM (FM-2, Fluorotron Master Ocular Fluorophotometer; OcuMetrics, Mountain View, California). The aqueous turnover protocol will be used to calculate the aqueous flow rate. Duplicate or triplicate scans will be collected and repeated at 1 hour intervals for 4 measurements to determine the aqueous flow rate (Ft).

  Four times during the morning through day 1 only (study completion)

Study Arms (3)

Healthy volunteers

healthy age matched with cases volunteers as controls

Uveitis with raised IOP

Recurrent (\> 5 attacks) idiopathic acute anterior uveitic with raised intraocular pressure

Uveitis with with normal IOP

Recurrent (\> 5 attacks) idiopathic acute anterior uveitic with normal intraocular pressure

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

30 patients will be included from each of these three group of patients: 1) recurrent (\> 5 attacks) idiopathic acute anterior uveitic with raised intraocular pressure; 2) recurrent (\> 5 attacks) idiopathic acute anterior uveitic without raised intraocular pressure; 3) healthy age matched volunteers as controls.

You may qualify if:

• Patients with idiopathic recurrent anterior uveitis with or without raised IOP.
• Normal healthy subjects with no ocular problems (other than refractive error) and IOP at screening \< 21mmHg.
• Age \>18 years.
• Adequate cognitive function and ability to understand verbal and written information in English.

You may not qualify if:

• Other secondary glaucomas including pigment dispersion syndrome and pseudoexfoliation.
• Normotensive glaucoma.
• Primary angle closure.
• Ocular trauma.
• Intraocular or keratorefractive surgery.
• Use of systemic medication that may affect aqueous humour production such as beta-blockers.
• A history of allergy or hypersensitivity to fluorescein.
• Any abnormalities preventing reliable IOP or fluorophotometric readings.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guys and St Thomas NHS Foundation Trust

London, SE1 7EH, United Kingdom

Location

Related Publications (1)

• Ho H, Daas A, Ho J, Alaghband P, Galvis EA, de Antonio Ramirez A, Grassi P, Lim R, Lim KS. Intraocular pressure changes following topical ocular hypotensive medications washout. Br J Ophthalmol. 2021 Feb;105(2):205-209. doi: 10.1136/bjophthalmol-2019-315778. Epub 2020 Apr 10.

  PMID: 32277009 DERIVED

MeSH Terms

Conditions

Uveitis, Anterior; Uveitis; Glaucoma

Condition Hierarchy (Ancestors)

Panuveitis; Uveal Diseases; Eye Diseases; Ocular Hypertension

Study Officials

• K Sheng l, MD

  Guy's and St Thomas NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: May 6, 2016
• Study Start: August 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 1, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)