An interventional study of OCT imaging in Optical Coherence Tomography (OCT) of the Retina, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-05.
Sponsored by Duke University · Not applicable, Interventional, and Diagnostic
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Among 28 studies in Ornithine Carbamoyltransferase Deficiency Disease with a site in United States — 6 open to participants now, 11 under way, 2 of them phase 3. Ornithine Carbamoyltransferase Deficiency Disease · United States.
Among the 28 studies in Ornithine Carbamoyltransferase Deficiency Disease with a site in United States, this one has the largest enrollment of the 12 interventional ones that give a count, is one of 4 that started in 2018, is the only one with no phase, and was the 12th registered.
59 studies on the registry are indexed under Ornithine Carbamoyltransferase Deficiency Disease; 13 are open to participants now.
Browse Ornithine Carbamoyltransferase Deficiency Disease studies →6 of the 28 studies in Ornithine Carbamoyltransferase Deficiency Disease with a site in United States are open now. Recruiting first, the newest first:
iECURE, Inc. · Sites in United States, France, United Kingdom
Ages 7 mo–15 mo
Arcturus Therapeutics, Inc. · Sites in United States
Ages 12+
Baylor College of Medicine · Sites in United States
Abbott Medical Devices · Sites in United States, Australia, Austria and 11 more countries
Ages 18+
Children's National Research Institute · Sites in United States
Ages 7–18
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 10 Ornithine Carbamoyltransferase Deficiency Disease studies recruiting now, 3 (30%) set no upper age limit and 6 (60%) stop at 75 or younger; 7 take children under 18; 3 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
28 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 6 · Phase 3 2
First in 2007; this study’s year is marked. 4 started in 2018.
This study's enrollment of 70 is above the median of 30 across 28 interventional studies indexed under Ornithine Carbamoyltransferase Deficiency Disease.
Median enrollment 15 across the 12 interventional studies, 66 across the 16 observational. Of the 17 that completed or were terminated, 7 (41%) have results posted.
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15 of 28 have an industry lead sponsor. The 10 most frequent:
Duke University is the lead sponsor of 2,063 studies on the registry; 272 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Duke University has 1 study filed under Ornithine Carbamoyltransferase Deficiency Disease — fewer than ten, so there is no comparison to draw.
3 of the studies in Ornithine Carbamoyltransferase Deficiency Disease with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05345171Phase 3Ultragenyx Pharmaceutical IncClinical Study of DTX301 AAV-Mediated Gene Transfer for Ornithine Transcarbamylase (OTC) Deficiency | 2027-09 |
| NCT03655223RTI InternationalEarly Check: Expanded Screening in Newborns | 2026-11-30 |
| NCT04612764Baylor College of MedicineLiver Disease in Urea Cycle Disorders | 2026-12-31 |
Add all 3 to your calendar (.ics) → With an account.
Among the 28 studies in Ornithine Carbamoyltransferase Deficiency Disease with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The purpose of this study is to compare the performance of a prototype optical coherence tomography (OCT) machine with currently available high resolution OCT machines.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
OCT device images retina
Device: OCT imaging
imaging of retina using OCT device
Number of Participants With Acceptable OCT Image Quality
measured by: ability to see clearly defined and recognizable structures of the retina with the low cost OCT device
Time frame: day 1
Central Macular Thickness
compare measurements of central macular thickness obtained with low cost OCT system and Heidelberg Spectralis OCT system
Time frame: day 1
Total Macular Volume
compare total macular volume measurements obtained with low cost OCT system and Heidelberg Spectralis OCT system
Time frame: day 1
| Milestone | OCT Imaging |
|---|---|
| Started | 70 |
| Completed | 70 |
| Not completed | 0 |
measured by: ability to see clearly defined and recognizable structures of the retina with the low cost OCT device
| Participants | OCT Imaging |
|---|---|
| Number of Participants With Acceptable OCT Image Quality | 60 |
compare measurements of central macular thickness obtained with low cost OCT system and Heidelberg Spectralis OCT system
No measurements were reported for this outcome.
compare total macular volume measurements obtained with low cost OCT system and Heidelberg Spectralis OCT system
No measurements were reported for this outcome.
Measure of OCT image quality comparing level of image contrast to level of background noise. CNR = (mean of signal of region of interest \[i.e., retina\] - mean of background noise) divided by square root of (the square of the standard deviation of the region of interest + the square of the standard deviation of the background noise). Therefore, CNR is unitless.
| unitless | OCT Imaging |
|---|---|
| Heidelberg Spectralis OCT device | 1.687 ± 0.027 |
| Low Cost OCT device | 1.592 ± 0.021 |
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| OCT Imaging | 0/70 (0%) | 0/70 (0%) | 0/70 (0%) |
| Age, Customized(Participants) | OCT Imaging |
|---|---|
| <= 50 years | 12 |
| 50 - 59 years | 6 |
| 60 - 69 years | 9 |
| 70 - 79 years | 13 |
| 80 - 89 years | 7 |
| >= 90 years | 1 |
| Unknown or Not Reported | 22 |
| Sex/Gender, Customized(Participants) | OCT Imaging |
|---|---|
| Male | 29 |
| Female | 40 |
| Unknown or Not Reported | 1 |
| Ethnicity (NIH/OMB)(Participants) | OCT Imaging |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 59 |
| Unknown or Not Reported | 10 |
| Race (NIH/OMB)(Participants) | OCT Imaging |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 8 |
| White | 48 |
| More than one race | 0 |
| Unknown or Not Reported | 11 |
| Retinal Pathology(Participants) | OCT Imaging |
|---|---|
| Participants with Retinal Pathology | 38 |
| Healthy Volunteers | 32 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Dec 2018, 8 months.
Results were first posted in Dec 2019, 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Ornithine Carbamoyltransferase Deficiency Disease →