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

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Brief Title

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.

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 Type

Interventional


Primary Outcome

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.


Condition

Uveitis

Intervention

Diclofenac

Study Arms / Comparison Groups

 Diclofenac
Description:  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 .

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

218

Start Date

September 2005

Completion Date

December 2010

Primary Completion Date

December 2009

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Tor B Elsås, Professor, , 

Location Countries

Norway

Location Countries

Norway

Administrative Informations


NCT ID

NCT00476593

Organization ID

47026200

Secondary IDs

NSD 200500943

Responsible Party

Sponsor

Study Sponsor

Norwegian University of Science and Technology

Collaborators

 St. Olavs Hospital

Study Sponsor

Tor B Elsås, Professor, Study Director, Department of Ophthalmology, St. Olavs University Hospital, Trondheim, Norway


Verification Date

March 2017