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Completed

NCT Number: NCT00476593

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diclofenac

Drug

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 names: Voltaren (Ophta SDU;Novartis Pharms) eye drops.

Dexamethasone

Drug

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 names: Spersadex (OmniVision, Novartis Pharma)eye drops.

Primary outcomes

  1. 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.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • St. Olavs Hospital

Registry information

Official study 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.

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
May 22, 2007
Registry last updated
May 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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