| Home | Search | Study Topics | Glossary |
|
|
|
 |
 |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Norwegian University of Science and Technology St. Olavs Hospital |
| Information provided by: | Norwegian University of Science and Technology |
| ClinicalTrials.gov Identifier: | NCT00476593 |
Purpose
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.
| Condition | Intervention |
|
Uveitis Iritis Iridocyclitis Anterior Uveitis |
Drug: Eye drops, mfERG and OCT scans |
| MedlinePlus related topics: | Anatomy Birth Control CT Scans Edema Nuclear Scans |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Open Label, Active Control, Parallel Assignment |
| Official Title: | 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. |
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2005 |
| Estimated Study Completion Date: | January 2009 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
A Diclofenac: Active Comparator
Diclofenac 1 mg/ml eye drops given to healthy volunteers four times a day for three days
|
Drug: Eye drops, mfERG and OCT scans
All participants were taken OCT scans of, some needed tropicamide 0.5% one drop in each eye to complete scan. MfERG testing was done, in order to complete such testing oxybuprocaine two drops and tropicamide one drop were given before the procedure. Contact lens electrode was placed on corneas and scans were taken. One group of healthy volunteers received dexamethasone 0.1% six times a day for three days, starting three days prior mfERG and OCT scans, while another group of healthy volunteers received diclofenac 1 mg/ml four times a day for three days prior to the testing.
|
|
B Dexamethasone: Active Comparator
Dexamethasone 0.1% was given six times a day for three days prior to testing to healthy volunteers
|
Drug: Eye drops, mfERG and OCT scans
All participants were taken OCT scans of, some needed tropicamide 0.5% one drop in each eye to complete scan. MfERG testing was done, in order to complete such testing oxybuprocaine two drops and tropicamide one drop were given before the procedure. Contact lens electrode was placed on corneas and scans were taken. One group of healthy volunteers received dexamethasone 0.1% six times a day for three days, starting three days prior mfERG and OCT scans, while another group of healthy volunteers received diclofenac 1 mg/ml four times a day for three days prior to the testing.
|
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Norway | |||||
| NTNU, DMF institutt for Nevromedisin | |||||
| Trondheim, Norway | |||||
| Norwegian University of Science and Technology |
| St. Olavs Hospital |
| Study Chair: | Tor Elsås, Professor | Ophtalmology department, St Olavs Hospital |
More Information
The faculty of NTU
|
| Responsible Party: | Norwegian University of Science and Technology ( Alexandra Wexler ) |
| Study ID Numbers: | 47026200, NSD 200500943, REK 4.2005.13 |
| First Received: | May 21, 2007 |
| Last Updated: | August 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00476593 |
| Health Authority: | Norway: The National Committees for Research Ethics in Norway |
|
|
|
|
|
|
|
