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

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.

Conditions

• Uveitis
• Iritis
• Iridocyclitis
• Anterior Uveitis
• Macular Edema

Interventions

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.

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.

Sponsors & Collaborators

• St. Olavs Hospital

  collaborator OTHER

• Norwegian University of Science and Technology

  lead OTHER

Principal Investigators

• Tor B Elsås, Professor · Department of Ophthalmology, St. Olavs University Hospital, Trondheim, Norway

• Trond Sand, Professor · Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway

• Alexandra Wexler, Dr · Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2005-09-30

Primary Completion

2009-12-31

Completion

2010-12-31

Countries

• Norway

Study Locations