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

Macular Edema Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00476593
• Other study ID #: 47026200
• Secondary ID: NSD 200500943REK
• Status: Completed
• Phase: N/A
• First received: May 21, 2007
• Last updated: August 9, 2011
• Start date: September 2005
• Est. completion date: December 2010

Study information

• Verified date: August 2011
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: December 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Norway	Department of Neuroscience, Norwegian University of Science and Technology	Trondheim
Norway	Department of Ophthalmology, St Olavs University Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Wexler A, Sand T, Elsås 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No