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Aqueous Humor Dynamics and Hypertensive 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: NCT02765308
Recruitment Status : Completed
First Posted : May 6, 2016
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

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.


Condition or disease
Uveitic Glaucoma Anterior Uveitis

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Study Type : Observational
Actual Enrollment : 94 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Contribution of Altered Aqueous Dynamics in the Development of Raised Intraocular Pressure in Patients With Uveitis
Study Start Date : August 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Group/Cohort
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



Primary Outcome Measures :
  1. Facility of outflow [ Time Frame: day 1 only (study completion) ]
    Tonographic outflow facility (C) will be performed using an electronic Schiøtz tonographer (Model 720, Berkeley Bioengineering Inc, USA) at 10AM

  2. Rate of aqueous flow (measured by fluorophotometry). [ Time Frame: Four times during the morning through day 1 only (study completion) ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

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): NCT02765308


Locations
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United Kingdom
Guys and St Thomas NHS Foundation Trust
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
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Principal Investigator: K Sheng l, MD Guy's and St Thomas NHS Foundation Trust
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02765308    
Other Study ID Numbers: 136787
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans to share IPD
Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Uveitis
Glaucoma
Aqueous humor dynamics
Additional relevant MeSH terms:
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Glaucoma
Uveitis
Uveitis, Anterior
Iridocyclitis
Ocular Hypertension
Eye Diseases
Uveal Diseases
Panuveitis
Iris Diseases