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. - Full Text View

Sponsor:	Norwegian University of Science and Technology
Collaborator:	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

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.

Resource links provided by NLM:

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Anatomy Birth Control Edema Nuclear Scans

Drug Information available for: Dexamethasone Diclofenac sodium Diclofenac potassium Diclofenac Dexamethasone acetate Doxiproct plus Tetrahydrozoline Tetrahydrozoline hydrochloride Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

Macular thickness and function [ Time Frame: days to weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Correlations between age, gender and contraception status with mfERG and OCT [ Time Frame: days to weeks ] [ Designated as safety issue: No ]

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.

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.

Detailed Description:

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476593

Locations

Norway
NTNU, DMF institutt for Nevromedisin
Trondheim, Norway

Sponsors and Collaborators

Norwegian University of Science and Technology

St. Olavs Hospital

Investigators

Study Chair:

Tor Elsås, Professor

Ophtalmology department, St Olavs Hospital

More Information

Additional Information:

The faculty of NTU This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Norwegian University of Science and Technology ( Alexandra Wexler )
Study ID Numbers:	47026200, NSD 200500943, REK 4.2005.13
Study First Received:	May 21, 2007
Last Updated:	December 30, 2008
ClinicalTrials.gov Identifier:	NCT00476593 History of Changes
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Keywords provided by Norwegian University of Science and Technology:

Uveitis
Iritis
Macular Thickness
HLA related
Macular edema
OCT

ERG
mfERG
Eye drops
Dexamethosone
Diclofenac

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Panuveitis
Uveitis, Anterior
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Hormones
Macular Edema
Iridocyclitis
Sensory System Agents
Uveitis
Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Retinal Diseases
Uveal Diseases
Antineoplastic Agents, Hormonal
Eye Diseases
Cyclooxygenase Inhibitors
Gastrointestinal Agents
Retinal Degeneration
Macular Degeneration
Diclofenac
Enzyme Inhibitors
Glucocorticoids
Pharmacologic Actions
Iris Diseases

ClinicalTrials.gov processed this record on November 09, 2009