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

NCT00476593 | Completed Results

• 3 other identifiers: 47026200NSD 200500943REK 4.2005.13
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 2

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.

Conditions

Uveitis; Iritis; Iridocyclitis; Anterior Uveitis; Macular Edema

Keywords

Uveitis; Iritis; Macular Thickness; HLA-B27 related; Macular edema; Macular thickening; OCT; mfERG; Eye drops; Dexamethosone; Diclofenac; Retinal aging

Outcome Measures

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.

  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.

  Macular thickness measured with the OCT

Study Arms (2)

Diclofenac

EXPERIMENTAL

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

Dexamethasone

EXPERIMENTAL

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

Interventions

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.

Also known as: Voltaren (Ophta SDU;Novartis Pharms) eye drops.

Diclofenac

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.

Also known as: Spersadex (OmniVision, Novartis Pharma)eye drops.

Dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults healthy volunteers and adult patients with anterior uveitis who wish to participate.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (2)

Department of Ophthalmology, St Olavs University Hospital

Trondheim, 7006, Norway

Location

Department of Neuroscience, Norwegian University of Science and Technology

Trondheim, 7491, Norway

Location

Related Publications (1)

• Wexler A, Sand T, Elsas TB. Macular thickness measurements in healthy Norwegian volunteers: an optical coherence tomography study. BMC Ophthalmol. 2010 May 13;10:13. doi: 10.1186/1471-2415-10-13.

  PMID: 20465801 RESULT

MeSH Terms

Conditions

Uveitis; Iritis; Iridocyclitis; Uveitis, Anterior; Macular Edema

Interventions

Diclofenac; Ophthalmic Solutions; Dexamethasone; dexamethasone 21-phosphate

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Iris Diseases; Panuveitis; Macular Degeneration; Retinal Degeneration; Retinal Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Dr Alexandra Wexler
• Organization: Department of Ophthalmology, St. Olavs Hospital, Trondheim Norway

a.wexler@online.no

99716763

Study Officials

• Tor B Elsås, Professor

  Department of Ophthalmology, St. Olavs University Hospital, Trondheim, Norway

  STUDY DIRECTOR

• Trond Sand, Professor

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

  STUDY CHAIR

• Alexandra Wexler, Dr

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2007
• First Posted: May 22, 2007
• Study Start: September 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2010
• Last Updated: May 1, 2017
• Results First Posted: June 22, 2011

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (2)