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

Primary Purpose

Uveitis, Iritis, Iridocyclitis

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Diclofenac
Dexamethasone
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Uveitis focused on measuring Uveitis, Iritis, Macular Thickness, HLA-B27 related, Macular edema, Macular thickening, OCT, mfERG, Eye drops, Dexamethosone, Diclofenac, Retinal aging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Ophthalmology, St Olavs University Hospital
  • Department of Neuroscience, Norwegian University of Science and Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Diclofenac

Dexamethasone

Arm 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 .

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.

Outcomes

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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 21, 2007
Last Updated
March 28, 2017
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00476593
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2005 (Actual)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diclofenac
Arm Type
Experimental
Arm 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 .
Arm Title
Dexamethasone
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Other Intervention Name(s)
Voltaren (Ophta SDU;Novartis Pharms) eye drops.
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Spersadex (OmniVision, Novartis Pharma)eye drops.
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Macular thickness measured with the OCT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tor B Elsås, Professor
Organizational Affiliation
Department of Ophthalmology, St. Olavs University Hospital, Trondheim, Norway
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Trond Sand, Professor
Organizational Affiliation
Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alexandra Wexler, Dr
Organizational Affiliation
Department of Neuroscience, Norwegian University of Science and Technology, Trondheim, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, St Olavs University Hospital
City
Trondheim
ZIP/Postal Code
7006
Country
Norway
Facility Name
Department of Neuroscience, Norwegian University of Science and Technology
City
Trondheim
ZIP/Postal Code
7491
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20465801
Citation
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.
Results Reference
result

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

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