Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00069199
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2003-09-17
Brief Title:
Optical Coherence Tomography Comparative Study
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Optical Coherence Tomography Comparative Study
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study conducted at the NIH Clinical Center and the University of Wisconsin University will compare measurements obtained using older and newer models of a machine called an optical coherence tomography OCT scanner This instrument uses a beam of light to measure the thickness of the retina the light-sensitive inner lining of the back of the eye OCT measurements will be done in multicenter clinical trials of new treatments for disorders that cause vision loss such as macular edema Because some centers in these studies will use the older OCT model and some the newer one it is necessary to determine whether the two models give comparable results
People 18 years of age and older in the following categories may be eligible for this study
People with diabetes with or without macular edema
People with other retinal disease such as uveitis or vein occlusion in the retina
People with no history of eye disease who have a normal retina
Participants will have the following tests and procedures
Eye examination to assess vision and eye pressure and to evaluate the retina The pupils are dilated with drops for this examination
Stereoscopic color fundus photography to examine the back of the eye Eye drops are used to enlarge the size of the pupils to allow for a through examination and photographs of the eye using a special camera that flashes a bright light into the eye
OCT to measure retinal thickness For this procedure the subject sits in front of a small screen and looks at a target in the center of the screen while a dim red light moves across the subjects retina This test is done first with one model of the OCT scanner then the other Finally the test is repeated in both eyes with whichever model was used first
Patients who are being treated for macular edema will repeat the same tests at their 3-month visits
People 18 years of age and older in the following categories may be eligible for this study
People with diabetes with or without macular edema
People with other retinal disease such as uveitis or vein occlusion in the retina
People with no history of eye disease who have a normal retina
Participants will have the following tests and procedures
Eye examination to assess vision and eye pressure and to evaluate the retina The pupils are dilated with drops for this examination
Stereoscopic color fundus photography to examine the back of the eye Eye drops are used to enlarge the size of the pupils to allow for a through examination and photographs of the eye using a special camera that flashes a bright light into the eye
OCT to measure retinal thickness For this procedure the subject sits in front of a small screen and looks at a target in the center of the screen while a dim red light moves across the subjects retina This test is done first with one model of the OCT scanner then the other Finally the test is repeated in both eyes with whichever model was used first
Patients who are being treated for macular edema will repeat the same tests at their 3-month visits
Detailed Description:
The use of the Optical Coherence Tomography OCT has increased markedly over the recent years for clinical research It is a promising new method for imaging the retina measuring its thickness and displaying some features of this structure It is useful in assessing several eye diseases including macular edema from various causes and abnormalities of the vitreoretinal interface There is a broad clinical consensus that OCT is superior to stereoscopic color fundus photography fluorescein angiography and clinical biomicroscopic examination in measuring retinal thickness and is capable of documenting fairly small changes in thickness OCT is becoming an important part of clinical trials of new treatments for macular edema A number of models of the OCT device are commercially available models 1 2 and 3 A number of models of OCT have been used in clinical centers involved in such clinical research Comparisons of these models 2 and 3 as well as the reproducibility of these measurements have not been conducted The main research questions to be answered in this protocol are the following in patients with normal retina diabetic macular edema macular edema from other causes or other vitreoretinal abnormalities
1 Is the standard deviation of the differences of sequential measurements of retinal thickness in normal retinas using OCT 3 similar to those measured with the OCT 2
2 Are there systematic differences between thickness measurements using OCT 2 and OCT 3 in the same eyes
3 Are there differences in the ability of each machine to image abnormalities within the vitreoretinal interface
1 Is the standard deviation of the differences of sequential measurements of retinal thickness in normal retinas using OCT 3 similar to those measured with the OCT 2
2 Are there systematic differences between thickness measurements using OCT 2 and OCT 3 in the same eyes
3 Are there differences in the ability of each machine to image abnormalities within the vitreoretinal interface
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-EI-0294 | None | None | None |