Retinal OCT and (mfERG) Related to Age, Sex, and the Use of Anti-inflammatory Medications

Not Applicable

Completed

• Conditions: Uveitis; Iritis; Iridocyclitis; Anterior Uveitis; Macular Edema
• Interventions: Drug: Dexamethasone; Drug: Diclofenac

• Registration Number: NCT00476593
• Lead Sponsor: Norwegian University of Science and Technology

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.

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2007-05-21
• Study First Submitted QC: 2007-05-21
• Study First Posted: 2007-05-22
• Primary Completion: 2009-12
• Study Completion: 2010-12
• Results First Submitted: 2011-05-24
• Results First Submitted QC: 2011-05-27
• Results First Posted: 2011-06-22
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone	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.
Diclofenac	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 .

Primary Outcome Measures

Name	Time	Method
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.	Macular thickness measured with the OCT	Macular thickness was assessed with the OCT in healthy subjects and in patients with anterior uveitis. Data was analyzed with respect to age, sex, parity, the use of hormonal therapy, after treatment with to types of anti-inflammatory eye drops, and in uncomplicated uveitis.

Trial Locations

Locations (2)

Department of Neuroscience, Norwegian University of Science and Technology; 🇳🇴 Trondheim, Norway

Department of Ophthalmology, St Olavs University Hospital; 🇳🇴 Trondheim, Norway