N/A
N=218
Retinal OCT and (mfERG) Related to Age, Sex, and the Use of Anti-inflammatory Medications
Uveitis · Iritis · Iridocyclitis · Anterior Uveitis · Macular Edema
Bottom Line
View on ClinicalTrials.gov: NCT00476593 ↗Enrolled (actual)
218
Serious AEs
—
Results posted
Jun 2011
Primary outcome: Primary: 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. — 268; 272; 276; 267 Macular Thickness in micron — p=0.018
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Diclofenac (Drug); Dexamethasone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Norwegian University of Science and Technology
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
268; 272; 276; 267 | 0.018 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00476593). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.