Retinal DiseaseNCT00069199
Optical Coherence Tomography Comparative Study
An observational study of Retinal Disease and Healthy, run by National Eye Institute (NEI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Retinal Disease, Healthy
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Aug 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient must understand and sign the informed consent.
- Patient must be at least 18 years of age.
- Pupillary dilation to at least 6 mm must be possible.
- Ocular media must be sufficiently clear to allow for quality images.
Who cannot join
- 1. Any condition such as corneal opacifiation that precludes adequate slit lamp examination and photography of the fundus.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Eye Institute (NEI)
Bethesda, Maryland, 20892
About this study
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:
Read more
- 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 subject's 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.
Read the 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:
- 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?
- Are there systematic differences between thickness measurements using OCT 2 and OCT 3 in the same eyes?
- Are there differences in the ability of each machine to image abnormalities within the vitreoretinal interface?
- Conditions
- Retinal Disease, Healthy
- Keywords
- Reproducibility, Macular Edema, OCT2, OCT3, Retina
- Medical subject headings
- Retinal Diseases, Macular Edema
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2003 (estimated)
- Study startSep 2003
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Retinal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00069199
- Sponsor's protocol ID
- 030294
- Other IDs
- 03-EI-0294
- Status last verified
- Aug 2005
- First submitted
- 17 Sep 2003
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Hee MR, Puliafito CA, Duker JS, Reichel E, Coker JG, Wilkins JR, Schuman JS, Swanson EA, Fujimoto JG. Topography of diabetic macular edema with optical coherence tomography. Ophthalmology. 1998 Feb;105(2):360-70. doi: 10.1016/s0161-6420(98)93601-6.
PubMed 9479300Strom C, Sander B, Larsen N, Larsen M, Lund-Andersen H. Diabetic macular edema assessed with optical coherence tomography and stereo fundus photography. Invest Ophthalmol Vis Sci. 2002 Jan;43(1):241-5.
PubMed 11773037Otani T, Kishi S, Maruyama Y. Patterns of diabetic macular edema with optical coherence tomography. Am J Ophthalmol. 1999 Jun;127(6):688-93. doi: 10.1016/s0002-9394(99)00033-1.
PubMed 10372879
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Comparative Study
- ClinicalTrials.gov ID
- NCT00069199
- Acronym / sponsor ID
- 030294
- Conditions
- Retinal Disease, Healthy
- Keywords
- Reproducibility, Macular Edema, OCT2, OCT3, Retina
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- Sep 2003
- Study completion
- Aug 2005
- First posted
- 18 Sep 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 subject's 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:
- 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?
- Are there systematic differences between thickness measurements using OCT 2 and OCT 3 in the same eyes?
- Are there differences in the ability of each machine to image abnormalities within the vitreoretinal interface?
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient must understand and sign the informed consent.
- Patient must be at least 18 years of age.
- Pupillary dilation to at least 6 mm must be possible.
- Ocular media must be sufficiently clear to allow for quality images.
Key exclusion criteria (1 listed)
- 1. Any condition such as corneal opacifiation that precludes adequate slit lamp examination and photography of the fundus.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 9479300Hee MR, Puliafito CA, Duker JS, Reichel E, Coker JG, Wilkins JR, Schuman JS, Swanson EA, Fujimoto JG. Topography of diabetic macular edema with optical coherence tomography. Ophthalmology. 1998 Feb;105(2):360-70. doi: 10.1016/s0161-6420(98)93601-6.
- Background: PubMed 11773037Strom C, Sander B, Larsen N, Larsen M, Lund-Andersen H. Diabetic macular edema assessed with optical coherence tomography and stereo fundus photography. Invest Ophthalmol Vis Sci. 2002 Jan;43(1):241-5.
- Background: PubMed 10372879Otani T, Kishi S, Maruyama Y. Patterns of diabetic macular edema with optical coherence tomography. Am J Ophthalmol. 1999 Jun;127(6):688-93. doi: 10.1016/s0002-9394(99)00033-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Disease and Healthy, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00069199, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008; AzTrials last refreshed its copy on 28 Oct 2026.