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

This study has been completed.

Study NCT00476593 Information provided by Norwegian University of Science and Technology

First Received on May 21, 2007. Last Updated on August 9, 2011 History of Changes

Results First Received: May 24, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Basic Science
Conditions:	Uveitis Iritis Iridocyclitis Anterior Uveitis Macular Edema
Interventions:	Drug: Diclofenac Drug: Dexamethasone

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Healthy subjects were recruited from students and staff at St. Olavs University Hospital and NTU for ophthalmic examination at the Department of Ophthalmology and mfERG testing at NTU, May 05- Sept. 07. From Sept.07 -sept.08 patients with uveitis were recruited from the Dep. of Opthalmology, healthy volunteers- both for OCT examination at the Dep.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
We chose to focus primary on the OCT results because mfERG equipement was moved and its software was updated. MfERG results will be analyzed later. The main reason for participant exclusion in this study was either bad OCT scan quality or participant withdrawal because examinations turned out to be more time consuming then they thought.

Reporting Groups

	Description
A 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 .
B 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.
Patients With Anterior Uveitis	Patients with anterior uveitis were recruited from the Department of Ophthalmology. They were treated for their uveitis and OCT scans of their both eyes were taken on follow up.
Healthy Volunteers	Healthy volunteers recruited from students and staff at St Olavs University hospital and NTU went through an opthalmologic examination and OCT scans were taken of their both eyes. This groups was to serve as healthy controls and as matching normative data for patients

Participant Flow: Overall Study

	A Diclofenac	B Dexamethasone	Patients With Anterior Uveitis	Healthy Volunteers
STARTED	32	19	38	129
COMPLETED	22 ^[1]	17 ^[2]	30	107
NOT COMPLETED	10	2	8	22
Lost to Follow-up	10	2	8	22

[1]	all subjects completed treatment in one eye. However, bilateral OCT scans included only in 22 cases
[2]	all subjects completed treatment in one eye. However, bilateral OCT scans included only in 17 cases

Baseline Characteristics

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Reporting Groups

	Description
A 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 .
B 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.
Patients With Anterior Uveitis	Patients with anterior uveitis were recruited from the Department of Ophthalmology. They were treated for their uveitis and OCT scans of their both eyes were taken on follow up.
Healthy Volunteers	Healthy volunteers recruited from students and staff at St Olavs University hospital and NTU went through an opthalmologic examination and OCT scans were taken of their both eyes. This groups was to serve as healthy controls and as matching normative data for patients

Baseline Measures

	A Diclofenac	B Dexamethasone	Patients With Anterior Uveitis	Healthy Volunteers	Total
Number of Participants [units: participants]	22	17	30	107	176
Age [units: participants]
<=18 years	0	0	0	0	0
Between 18 and 65 years	22	17	29	107	175
>=65 years	0	0	1	0	1
Age [units: years] Mean ± Standard Deviation	44.2 ± 10.9	46.2 ± 11.4	40.5 ± 2.3	42.4 ± 11.8	45.1 ± 11
Gender [units: participants]
Female	15	13	15	62	105
Male	7	4	15	45	71
Region of Enrollment [units: participants]
Norway	22	17	30	107	176

Outcome Measures

1. 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. [ Time Frame: Macular thickness measured with the OCT ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Dr Alexandra Wexler
Organization: Department of Ophthalmology, St. Olavs Hospital, Trondheim Norway
phone: 99716763 ext 0074
e-mail: a.wexler@online.no

Publications of Results:

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.

Responsible Party:	Dr Alexandra Wexler, Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00476593 History of Changes
Other Study ID Numbers:	47026200, NSD 200500943, REK 4.2005.13
Study First Received:	May 21, 2007
Results First Received:	May 24, 2011
Last Updated:	August 9, 2011
Health Authority:	Norway: The National Committees for Research Ethics in Norway