Trial Outcomes & Findings for Retinal OCT and (mfERG) Related to Age, Sex, and the Use of Anti-inflammatory Medications (NCT NCT00476593)

Last Updated: 2017-05-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

218 participants

Primary outcome timeframe

Macular thickness measured with the OCT

Results posted on

2017-05-01

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	32	19	38	129
Overall Study COMPLETED	22	17	30	107
Overall Study NOT COMPLETED	10	2	8	22

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Lost to Follow-up	10	2	8	22

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A Diclofenac n=22 Participants 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 n=17 Participants 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 n=30 Participants 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 n=107 Participants 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	Total n=176 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	17 Participants n=7 Participants	29 Participants n=5 Participants	107 Participants n=4 Participants	175 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Age, Continuous	44.2 years STANDARD_DEVIATION 10.9 • n=5 Participants	46.2 years STANDARD_DEVIATION 11.4 • n=7 Participants	40.5 years STANDARD_DEVIATION 2.3 • n=5 Participants	42.4 years STANDARD_DEVIATION 11.8 • n=4 Participants	45.1 years STANDARD_DEVIATION 11 • n=21 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	13 Participants n=7 Participants	15 Participants n=5 Participants	62 Participants n=4 Participants	105 Participants n=21 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants	45 Participants n=4 Participants	71 Participants n=21 Participants
Region of Enrollment Norway	22 participants n=5 Participants	17 participants n=7 Participants	30 participants n=5 Participants	107 participants n=4 Participants	176 participants n=21 Participants

PRIMARY outcome

Timeframe: Macular thickness measured with the OCT

Population: Enrolled healthy subjects and patients with anterior uveitis who volunteered through enrollment period

Outcome measures

Outcome measures
Measure	A Diclofenac n=22 Participants 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 n=17 Participants 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 n=30 Participants 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 n=107 Participants 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
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.	268 Macular Thickness in micron Standard Deviation 13	272 Macular Thickness in micron Standard Deviation 16	276 Macular Thickness in micron Standard Deviation 21	267 Macular Thickness in micron Standard Deviation 13

Adverse Events

A Diclofenac

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

B Dexamethasone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patients With Anterior Uveitis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy Volunteers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Alexandra Wexler

Department of Ophthalmology, St. Olavs Hospital, Trondheim Norway

Phone: 99716763

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place