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Changes in Multifocal Electroretinogram (mfERG) and Optical Coherence Tomography (OCT) as a Gauge for Inflammatory Activity and Macular Edema in Anterior Uveitis; Establishing Normal Ranges; Age, Gender and Contraception Status. Correlation Between Anatomy and Function.
This study is ongoing, but not recruiting participants.
Study NCT00476593   Information provided by Norwegian University of Science and Technology
First Received: May 21, 2007   Last Updated: December 30, 2008   History of Changes

May 21, 2007
December 30, 2008
September 2005
February 2008   (final data collection date for primary outcome measure)
Macular thickness and function [ Time Frame: days to weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00476593 on ClinicalTrials.gov Archive Site
Correlations between age, gender and contraception status with mfERG and OCT [ Time Frame: days to weeks ] [ Designated as safety issue: No ]
Same as current
 
Changes in Multifocal Electroretinogram (mfERG) and Optical Coherence Tomography (OCT) as a Gauge for Inflammatory Activity and Macular Edema in Anterior Uveitis; Establishing Normal Ranges; Age, Gender and Contraception Status. Correlation Between Anatomy and Function.
Changes in Multifocal Electroretinogram and Optical Coherence Tomography as a Gauge for Inflammatory Activity and Macular Edema Developement in Anterior Uveitis Patients, Compared to Healthy Volunteers; Possible Indicator for Blindness Preventive Treatment.

Multifocal ElectroRetinogram (mfERG) is a relatively new method for an objective assessment of central retinal function, while Optical Coherence Tomography (OCT) is an established technology which has become popular in the clinics for the anatomical study of the same retinal region. This study is to evaluate whether uncomplicated anterior uveitis leads to anatomical changes in the macular region on OCT and /or functional changes on mfERG.

We have collected OCT scans and mfERG recordings from patients with current anterior uveitis on follow up until the uveitis went into remission. Since we did not have normal ranges for neither OCT nor mfERG values we had also to recruit healthy subjects to go through same tests.

Patients with anterior uveitis were receiving treatment with eye drops until the inflammation declined, we asked also healthy subjects to apply eye drops in one eye to test the effect of the uveitis treatment on macular function and anatomy. We wished to show that the uveitis and not the treatment of it leads to changes in the tests. Only this part of the study is interventional, the intervention is with two types of eye drops which are widely used in the clinics.

Both OCT and mfERG results in healthy subjects are to be analysed for statistical correlations with age, gender and contraception status, to see whether these factors need to be taken into consideration when analyzing results from patients. Results of these tests are to be published consecutively in several different publications. Test results from patients are so to be statistically compared to those from healthy subjects, possibly in stratified groups (according to the results from the preliminary testing of healthy subjects) and results are anticipated to be published separately for OCT and mfERG. Correlation studies of mfERG with OCT in patients with anterior uveitis would hopefully also be available for a publishing towards the end of the trial period.

 
Interventional
Basic Science, Randomized, Open Label, Active Control, Parallel Assignment
  • Uveitis
  • Iritis
  • Iridocyclitis
  • Anterior Uveitis
Drug: Eye drops, mfERG and OCT scans
  • Active Comparator: Diclofenac 1 mg/ml eye drops given to healthy volunteers four times a day for three days
  • Active Comparator: Dexamethasone 0.1% was given six times a day for three days prior to testing to healthy volunteers
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
100
January 2009
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults healthy volunteers and adult patients with anterior uveitis who wish to participate

Exclusion Criteria:

  • Patients with anterior uveitis who have other systemic diseases in addition to anterior uveitis.
  • Patients with anterior uveitis who do not wish to participate.
  • Patients who are allergic to local anesthesia or mydriatics
  • Patients who cannot receive mydriatics.
  • Patients with diagnosed or suspected epilepsia.
  • Persons who have had an operation on their eyes.
  • Persons with diagnosed or suspected eye disease other than anterior uveitis.
  • Persons with high myopia or high hyperopia.
  • Subjects who cooperate poorly.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00476593
Alexandra Wexler, Norwegian University of Science and Technology
47026200, NSD 200500943, REK 4.2005.13
Norwegian University of Science and Technology
St. Olavs Hospital
Study Chair: Tor Elsås, Professor Ophtalmology department, St Olavs Hospital
Norwegian University of Science and Technology
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP