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| 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
Retinal optical coherence tomography (OCT) is an established technology which enables a detailed cross-sectional visualization of the retinal micro-anatomy, and an objective measurement of its thickness in-vivo. Multifocal electroretinogram (MfERG) measures function of the central retina. Both technologies are relatively new and they provide complimentary to each other information on retinal anatomy and function.
The aims of this study is to establish normal ranges for OCT and mfERG measurements related to age, gender and reproductive factors such as parity and the use of contraception in Norwegians; to assess the presumably healthy central retina with the use of anti-inflammatory medication with relation to age and sex ; to study the frequency and extent of retinal thickening and change in retinal function in patients with anterior uveitis not complicated with macular edema; to assess whether the presence of the HLA-B27 haplotype or uveitis recidive affects macular thickening/function in uveitis.
| Condition | Intervention |
|---|---|
|
Uveitis Iritis Iridocyclitis Anterior Uveitis Macular Edema |
Drug: Diclofenac Drug: Dexamethasone |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Retinal Optical Coherence Tomography and Multifocal Electroretinogram; Establishing Normal Ranges Related to Age and Reproductive Factors; With the Use of Anti-inflammatory Medications;In Uncomplicated Anterior Uveitis; Anatomy and Function. |
| Enrollment: | 218 |
| Study Start Date: | September 2005 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Diclofenac
Preservative- free Diclofenac Na 0.1 % eye drops were applied in one consecutively assigned eye of healthy volunteers four times a day for three days, after which macular thichness was measured in both subjects' eyes with the OCT .
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Drug: Diclofenac
Preservative- free Diclofenac Na 0.1% eye drops (Voltaren Ophta SDU;Novartis Pharms). One drop four times daily in one eys for three days. The evaluation of macular thickness/function after 3 days use of anti-inflammatory eye drops in healthy subjects is the only sub-study involving an intervention design. Other Name: Voltaren (Ophta SDU;Novartis Pharms) eye drops.
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Experimental: Dexamethasone
Benzalkonium-reserved Dexamethasone Sodium Phosphate 0.1% was applied in one consecutively assigned eye of healthy volunteers six times a day for three days, after which macular thickness was assessed in both subjects's eyes with the OCT.
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Drug: Dexamethasone
Dexamethasone sodium phosphate 0.1% eye drops (Spersadex OmniVision, Novartis Pharma), one drop six times daily for three days in one eye. Pharms). One drop four times daily in one eys for three days. The evaluation of macular thickness/function after 3 days use of anti-inflammatory eye drops in healthy subjects is the only sub-study involving an intervention design. Other Name: Spersadex (OmniVision, Novartis Pharma)eye drops.
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Normal optical coherence tomography (OCT) and Multifocal electroretinogram (MfERG) measurements may vary with race, age, sex, parity and the use of hormone therapy in health. It has therefore been recommended to gather normative data on the individual OCT/MfERG equipment in each laboratory. This is the reason why we gathered our local normative material on both machines. We also assessed our normative material on the OCT in relation to age, sex, parity and the use of contraception for future matching with patients.
It has been hypothesized that para-inflammation states are involved in retinal aging in health. We assume that the age-related changes we observed in our normative OCT material are related to low-grade chronic inflammation in the retina. We therefore assessed the effect of to commercially available anti-inflammatory eye drops- diclofenac and dexamethasone,which are often used in inflammation-related states in ophthalmology for their effect on macular thickness in health and with aging.
Uveitis is a frank intraocular inflammation which may lead to macular edema. Macular edema is often transient in uveitis and its presence has been previously reported in severe or long-lasting uveitis. In some cases mecular edema may become chronic or refractory to treatment. However, whether uncomplicated anterior uveitis with no clinically evident macular edema leads to macular thickening detectable with the OCT, or whether monolateral uveitis may cause bilateral macular thickening is not known. We therefore assesed both eyes of patients with anterior uveitis for macular thickening with the OCT.
To correlate macular anatomy with its function some subjects included in the OCT study were also examined with the mfERG. However, at present the MfERG result have not been analyzed.
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:
Contacts and Locations| Norway | |
| Department of Neuroscience, Norwegian University of Science and Technology | |
| Trondheim, Norway, 7491 | |
| Department of Ophthalmology, St Olavs University Hospital | |
| Trondheim, Norway, 7006 | |
| Study Director: | Tor B Elsås, Professor | Department of Ophthalmology, St. Olavs University Hospital, Trondheim, Norway |
| Study Chair: | Trond Sand, Professor | Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway |
| Principal Investigator: | Alexandra Wexler, Dr | Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway |
More Information
| Responsible Party: | Dr Alexandra Wexler, Norwegian University of Science and Technology |
| ClinicalTrials.gov Identifier: | NCT00476593 History of Changes |
| Other Study ID Numbers: | 47026200, NSD 200500943, REK 4.2005.13 |
| Study First Received: | May 21, 2007 |
| Results First Received: | May 24, 2011 |
| Last Updated: | August 9, 2011 |
| Health Authority: | Norway: The National Committees for Research Ethics in Norway |
|
Uveitis Iritis Macular Thickness HLA-B27 related Macular edema Macular thickening |
OCT mfERG Eye drops Dexamethosone Diclofenac Retinal aging |
|
Edema Iridocyclitis Iritis Macular Edema Uveitis Uveitis, Anterior Signs and Symptoms Iris Diseases Uveal Diseases Eye Diseases Panuveitis Macular Degeneration Retinal Degeneration Retinal Diseases Dexamethasone acetate |
Anti-Inflammatory Agents Dexamethasone Diclofenac Dexamethasone 21-phosphate Tetrahydrozoline BB 1101 Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids |
