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

NCT ID: NCT00476593

Last Updated: 2017-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2010-12-31

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.

Conditions

Uveitis; Iritis; Iridocyclitis; Anterior Uveitis; Macular Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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 .

Group Type: EXPERIMENTAL

Diclofenac

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Dexamethasone

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Voltaren (Ophta SDU;Novartis Pharms) eye drops.; Spersadex (OmniVision, Novartis Pharma)eye drops.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tor B Elsås, Professor

Role: STUDY_DIRECTOR

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

Trond Sand, Professor

Role: STUDY_CHAIR

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

Alexandra Wexler, Dr

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Department of Ophthalmology, St Olavs University Hospital

Trondheim, , Norway

Department of Neuroscience, Norwegian University of Science and Technology

Trondheim, , Norway

Countries

Norway

References

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.

Reference Type: RESULT

PMID: 20465801 (View on PubMed)

Other Identifiers

NSD 200500943

Identifier Type: OTHER

Identifier Source: secondary_id

REK 4.2005.13

Identifier Type: OTHER

Identifier Source: secondary_id

47026200

Identifier Type: -

Identifier Source: org_study_id