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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | May 21, 2007 | ||||
| Last Updated Date | December 30, 2008 | ||||
| Start Date ICMJE | September 2005 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Macular thickness and function [ Time Frame: days to weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00476593 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Correlations between age, gender and contraception status with mfERG and OCT [ Time Frame: days to weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | 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. | ||||
| Official Title ICMJE | 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. | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Basic Science, Randomized, Open Label, Active Control, Parallel Assignment | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Eye drops, mfERG and OCT scans | ||||
| Study Arms / Comparison Groups |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | January 2009 | ||||
| Primary Completion Date | February 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Norway | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00476593 | ||||
| Responsible Party | Alexandra Wexler, Norwegian University of Science and Technology | ||||
| Study ID Numbers ICMJE | 47026200, NSD 200500943, REK 4.2005.13 | ||||
| Study Sponsor ICMJE | Norwegian University of Science and Technology | ||||
| Collaborators ICMJE | St. Olavs Hospital | ||||
| Investigators ICMJE |
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| Information Provided By | Norwegian University of Science and Technology | ||||
| Verification Date | August 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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