Clinical trial NCT00476593: Retinal OCT and (mfERG) Related to Age, Sex, and the Use of Anti-inflammatory Medications
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uveitis
Iritis
Iridocyclitis
Anterior Uveitis
Macular Edema
Keywords: Uveitis
Iritis
Macular Thickness
HLA-B27 related
Macular edema
Macular thickening
OCT
mfERG
Eye drops
Dexamethosone
Diclofenac
Retinal aging
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2007-05-22
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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 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/conditions not related to their anterior uveitis, like high blood pressure, diabetes or epilepsy.
* Patients with ocular comorbidity or compliactions to their anterior uveitis, such as elevated ocular pressure or glaucoma.
* Previous or current macular edema or other posterior segment complications related to uveitis.
* Subjects with visual acuity worse than 0.8
* Subjects/patients with cataracts or other ocular media opacities
* Subjects/patients who are allergic to local anesthesia or mydriatics.
* Subjects/patients with high myopia/hyperopia
* Subjects/patients who have had intraocular surgery, although previous uncomplicated LASIK correction for low-grade myopia were accepted.
* Subjects/patients who cooperate poorly.

Primary outcomes:
measure: Macular Thickness Measured With the OCT; in Relation to Age, Sex, Reproductive Factors and the Use of Anti-inflammatory Eye Drops in Health; in Uncomplicated Anterior Uveitis.
timeFrame: Macular thickness measured with the OCT
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of Ophthalmology, St Olavs University Hospital
city: Trondheim
country: Norway
facility: Department of Neuroscience, Norwegian University of Science and Technology
Study officials:
affiliation: Department of Ophthalmology, St. Olavs University Hospital, Trondheim, Norway
name: Tor B Elsås, Professor
role: STUDY_DIRECTOR
affiliation: Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway
name: Trond Sand, Professor
role: STUDY_CHAIR
affiliation: Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway
name: Alexandra Wexler, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wexler A, Sand T, Elsas TB. Macular thickness measurements in healthy Norwegian volunteers: an optical coherence tomography study. BMC Ophthalmol. 2010 May 13;10:13. doi: 10.1186/1471-2415-10-13.