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

This study has been completed.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by:
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00476593
First received: May 21, 2007
Last updated: August 9, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Uveitis
Iritis
Iridocyclitis
Anterior Uveitis
Macular Edema
Drug: Diclofenac
Drug: Dexamethasone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
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.

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 218
Study Start Date: September 2005
Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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 .
Drug: Diclofenac

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 Name: Voltaren (Ophta SDU;Novartis Pharms) eye drops.
Experimental: 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.
Drug: Dexamethasone

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00476593

Locations
Norway
Department of Neuroscience, Norwegian University of Science and Technology
Trondheim, Norway, 7491
Department of Ophthalmology, St Olavs University Hospital
Trondheim, Norway, 7006
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Study Director: Tor B Elsås, Professor Department of Ophthalmology, St. Olavs University Hospital, Trondheim, Norway
Study Chair: Trond Sand, Professor Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway
Principal Investigator: Alexandra Wexler, Dr Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway
  More Information

Publications:
Responsible Party: Dr Alexandra Wexler, Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00476593     History of Changes
Other Study ID Numbers: 47026200, NSD 200500943, REK 4.2005.13
Study First Received: May 21, 2007
Results First Received: May 24, 2011
Last Updated: August 9, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
Uveitis
Iritis
Macular Thickness
HLA-B27 related
Macular edema
Macular thickening
OCT
mfERG
Eye drops
Dexamethosone
Diclofenac
Retinal aging

Additional relevant MeSH terms:
Chorioretinitis
Iridocyclitis
Macular Edema
Uveitis
Uveitis, Anterior
Choroid Diseases
Choroiditis
Eye Diseases
Iris Diseases
Macular Degeneration
Panuveitis
Retinal Degeneration
Retinal Diseases
Retinitis
Uveal Diseases
Uveitis, Posterior
Anti-Inflammatory Agents
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Diclofenac
Lactitol
Ophthalmic Solutions
Tetrahydrozoline
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents, Non-Steroidal
Antiemetics
Antineoplastic Agents

ClinicalTrials.gov processed this record on November 25, 2014