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Trial record 5 of 8 for:    "Iritis"

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

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ClinicalTrials.gov Identifier: NCT00476593
Recruitment Status : Completed
First Posted : May 22, 2007
Results First Posted : June 22, 2011
Last Update Posted : May 1, 2017
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Uveitis
Iritis
Iridocyclitis
Anterior Uveitis
Macular Edema
Interventions Drug: Diclofenac
Drug: Dexamethasone
Enrollment 218
Recruitment Details 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 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.
Arm/Group Title A Diclofenac B Dexamethasone Patients With Anterior Uveitis Healthy Volunteers
Hide Arm/Group 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. 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 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
Period Title: Overall Study
Started 32 19 38 129
Completed 22 [1] 17 [2] 30 107
Not Completed 10 2 8 22
Reason Not Completed
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
Arm/Group Title A Diclofenac B Dexamethasone Patients With Anterior Uveitis Healthy Volunteers Total
Hide Arm/Group 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. 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 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 of all reporting groups
Overall Number of Baseline Participants 22 17 30 107 176
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 17 participants 30 participants 107 participants 176 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
 100.0%
17
 100.0%
29
  96.7%
107
 100.0%
175
  99.4%
>=65 years
0
   0.0%
0
   0.0%
1
   3.3%
0
   0.0%
1
   0.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 17 participants 30 participants 107 participants 176 participants
44.2  (10.9) 46.2  (11.4) 40.5  (2.3) 42.4  (11.8) 45.1  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 17 participants 30 participants 107 participants 176 participants
Female
15
  68.2%
13
  76.5%
15
  50.0%
62
  57.9%
105
  59.7%
Male
7
  31.8%
4
  23.5%
15
  50.0%
45
  42.1%
71
  40.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Norway Number Analyzed 22 participants 17 participants 30 participants 107 participants 176 participants
22 17 30 107 176
1.Primary Outcome
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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Enrolled healthy subjects and patients with anterior uveitis who volunteered through enrollment period
Arm/Group Title A Diclofenac B Dexamethasone Patients With Anterior Uveitis Healthy Volunteers
Hide Arm/Group 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.
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 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 Number of Participants Analyzed 22 17 30 107
Mean (Standard Deviation)
Unit of Measure: Macular Thickness in micron
268  (13) 272  (16) 276  (21) 267  (13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A Diclofenac, B Dexamethasone
Comments Subjects who received diclofenac or dexamethasone eye drops in one eye. Macular thickness in both were compared between same subjects' eyes after 3 day's treatment. Diclofenac and dexamethasone treated eyes were not compared with each other, but with the contralateral eye of same subject by a paired Student's t-test in each medication group
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.018
Comments Hypothesis: the use of diclofenac/dexamethasone does not influence macular thickness in treated eyes compared with untreated eyes of same subject.
Method t-test, 2 sided
Comments The possible effect of both anti-inflammatory medications was tested in relation to participants' age and gender
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Patients With Anterior Uveitis, Healthy Volunteers
Comments Patient's healthy eyes were compared with sex and age matched healthy controls with Two Sample Student't t-test. Null hypothesis was that quiet, currently unaffected eyes of patients had same macular thickness as age and sex matched controls.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.024
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A Diclofenac B Dexamethasone Patients With Anterior Uveitis Healthy Volunteers
Hide Arm/Group 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. 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 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
All-Cause Mortality
A Diclofenac B Dexamethasone Patients With Anterior Uveitis Healthy Volunteers
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
A Diclofenac B Dexamethasone Patients With Anterior Uveitis Healthy Volunteers
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
A Diclofenac B Dexamethasone Patients With Anterior Uveitis Healthy Volunteers
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0   0/0   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Alexandra Wexler
Organization: Department of Ophthalmology, St. Olavs Hospital, Trondheim Norway
Phone: 99716763 ext 0074
EMail: a.wexler@online.no
Layout table for additonal information
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00476593     History of Changes
Other Study ID Numbers: 47026200
NSD 200500943 ( Other Identifier: Helse Midt-Norge )
REK 4.2005.13 ( Other Identifier: Helse Midt-Norge )
First Submitted: May 21, 2007
First Posted: May 22, 2007
Results First Submitted: May 24, 2011
Results First Posted: June 22, 2011
Last Update Posted: May 1, 2017