Studies
| Study First Submitted Date | 2023-01-06 |
| Study First Posted Date | 2023-01-17 |
| Last Update Posted Date | 2023-05-06 |
| Start Month Year | March 30, 2023 |
| Primary Completion Month Year | April 28, 2023 |
| Verification Month Year | May 2023 |
| Verification Date | 2023-05-31 |
| Last Update Posted Date | 2023-05-06 |
Facilities
| Sequence: | 198702620 |
| Name | NYU Langone Health |
| City | New York |
| State | New York |
| Zip | 10017 |
| Country | United States |
Conditions
| Sequence: | 51815065 | Sequence: | 51815066 | Sequence: | 51815067 | Sequence: | 51815068 | Sequence: | 51815069 | Sequence: | 51815070 |
| Name | Age-Related Macular Degeneration | Name | Diabetic Retinopathy | Name | Central Serous Chorioretinopathy | Name | Glaucoma | Name | Glaucoma, Suspect | Name | Eye Diseases |
| Downcase Name | age-related macular degeneration | Downcase Name | diabetic retinopathy | Downcase Name | central serous chorioretinopathy | Downcase Name | glaucoma | Downcase Name | glaucoma, suspect | Downcase Name | eye diseases |
Id Information
| Sequence: | 39874987 |
| Id Source | org_study_id |
| Id Value | 22-01420 |
Countries
| Sequence: | 42273531 |
| Name | United States |
| Removed | False |
Design Groups
| Sequence: | 55236755 | Sequence: | 55236756 | Sequence: | 55236757 | Sequence: | 55236758 |
| Group Type | Experimental | Group Type | Experimental | Group Type | Experimental | Group Type | Experimental |
| Title | Device C (OD-OS), then Device N (OD-OS) | Title | Device C (OS-OD), then Device N (OS-OD) | Title | Device N (OD-OS), then Device C (OD-OS) | Title | Device N (OS-OD), then Device C (OS-OD) |
| Description | Participants will be randomized to receive 1 macular scan on each eye and 1 optic nerve head (ONH) scan on each eye from two devices: device C, a standard conventional device with no attachment; and device N, the standard conventional device with the invention (comfortable chin and forehead rest that can be adjusted to fit each individual's size) attached to the device. Participants will first be imaged using device C starting with the right eye (OD), then left eye (OS). They will then be imaged using device N, starting with OD, then OS. | Description | Participants will be randomized to receive 1 macular scan on each eye and 1 optic nerve head (ONH) scan on each eye from two devices: device C, a standard conventional device with no attachment; and device N, the standard conventional device with the invention (comfortable chin and forehead rest that can be adjusted to fit each individual's size) attached to the device. Participants will first be imaged using device C starting with the left eye (OS), then right eye (OD). They will then be imaged using device N, starting with OS, then OD. | Description | Participants will be randomized to receive 1 macular scan on each eye and 1 optic nerve head (ONH) scan on each eye from two devices: device N, a standard conventional device with the invention (comfortable chin and forehead rest that can be adjusted to fit each individual's size) attached to the device; and device C, the standard conventional device with no attachment. Participants will first be imaged using device N starting with the right eye (OD), then left eye (OS). They will then be imaged using device C, starting with OD, then OS. | Description | Participants will be randomized to receive 1 macular scan on each eye and 1 optic nerve head (ONH) scan on each eye from two devices: device N, a standard conventional device with the invention (comfortable chin and forehead rest that can be adjusted to fit each individual's size) attached to the device; and device C, the standard conventional device with no attachment. Participants will first be imaged using device N starting with the left eye (OS), then right eye (OD). They will then be imaged using device C, starting with OS, then OD. |
Interventions
| Sequence: | 52136878 | Sequence: | 52136879 |
| Intervention Type | Device | Intervention Type | Device |
| Name | OCT Imaging Using Device N | Name | OCT Imaging Using Device C |
| Description | Standard conventional OCT imaging device equipped with extendable and comfortable chin and forehead rest. | Description | Standard conventional OCT imaging device. |
Design Outcomes
| Sequence: | 176226941 | Sequence: | 176226942 | Sequence: | 176226943 | Sequence: | 176226944 | Sequence: | 176226945 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | primary | Outcome Type | secondary | Outcome Type | secondary |
| Measure | Percentage of Participants who Indicate Device N Provided a More Comfortable Experience, Compared with Device C | Measure | Comfort Level Rating of Device N on 0-5 Scale | Measure | Comfort Level Rating of Device C on 0-5 Scale | Measure | Time Duration to Adjust for Number of Motion Artifacts Present with Device N Imaging | Measure | Time Duration to Adjust for Number of Motion Artifacts Present with Device C Imaging |
| Time Frame | Post-Imaging Session (Day 1) | Time Frame | Post-Imaging Session (Day 1) | Time Frame | Post-Imaging Session (Day 1) | Time Frame | Imaging Session (Day 1) | Time Frame | Imaging Session (Day 1) |
| Description | Participants will be asked which device provided a more comfortable experience: Device C or Device N. | Description | Participants will be asked to rate how comfortable Device N was, on a scale of 0-5. Higher scores indicate higher levels of comfort. | Description | Participants will be asked to rate how comfortable Device N was, on a scale of 0-5. Higher scores indicate higher levels of comfort. | Description | The OCT imaging device includes an "eye tracking" feature that selects a specific location within the eye and constantly adjusts, i.e. tracks, for fine fixation adjustments that occur when a patient's eye is moving very slightly during imaging. The time to adjust for the number of motion artifacts present will be defined as the duration it takes from the moment the imager clicks "Acquire" on the device to when the progress bar is "Full." | Description | The OCT imaging device includes an "eye tracking" feature that selects a specific location within the eye and constantly adjusts, i.e. tracks, for fine fixation adjustments that occur when a patient's eye is moving very slightly during imaging. The time to adjust for the number of motion artifacts present will be defined as the duration it takes from the moment the imager clicks "Acquire" on the device to when the progress bar is "Full." |
Browse Conditions
| Sequence: | 192052596 | Sequence: | 192052597 | Sequence: | 192052598 | Sequence: | 192052599 | Sequence: | 192052601 | Sequence: | 192052594 | Sequence: | 192052595 | Sequence: | 192052600 | Sequence: | 192052602 | Sequence: | 192052603 | Sequence: | 192052604 | Sequence: | 192052605 | Sequence: | 192052606 | Sequence: | 192052607 |
| Mesh Term | Diabetic Retinopathy | Mesh Term | Eye Diseases | Mesh Term | Central Serous Chorioretinopathy | Mesh Term | Ocular Hypertension | Mesh Term | Retinal Diseases | Mesh Term | Glaucoma | Mesh Term | Macular Degeneration | Mesh Term | Retinal Degeneration | Mesh Term | Diabetic Angiopathies | Mesh Term | Vascular Diseases | Mesh Term | Cardiovascular Diseases | Mesh Term | Diabetes Complications | Mesh Term | Diabetes Mellitus | Mesh Term | Endocrine System Diseases |
| Downcase Mesh Term | diabetic retinopathy | Downcase Mesh Term | eye diseases | Downcase Mesh Term | central serous chorioretinopathy | Downcase Mesh Term | ocular hypertension | Downcase Mesh Term | retinal diseases | Downcase Mesh Term | glaucoma | Downcase Mesh Term | macular degeneration | Downcase Mesh Term | retinal degeneration | Downcase Mesh Term | diabetic angiopathies | Downcase Mesh Term | vascular diseases | Downcase Mesh Term | cardiovascular diseases | Downcase Mesh Term | diabetes complications | Downcase Mesh Term | diabetes mellitus | Downcase Mesh Term | endocrine system diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 47987630 | Sequence: | 47987631 |
| Agency Class | OTHER | Agency Class | NIH |
| Lead Or Collaborator | lead | Lead Or Collaborator | collaborator |
| Name | NYU Langone Health | Name | National Eye Institute (NEI) |
Overall Officials
| Sequence: | 29076068 |
| Role | Principal Investigator |
| Name | Chaim Gadi Wollstein, MD |
| Affiliation | NYU Langone Health |
Design Group Interventions
| Sequence: | 67718814 | Sequence: | 67718815 | Sequence: | 67718816 | Sequence: | 67718817 | Sequence: | 67718818 | Sequence: | 67718819 | Sequence: | 67718820 | Sequence: | 67718821 |
| Design Group Id | 55236755 | Design Group Id | 55236756 | Design Group Id | 55236757 | Design Group Id | 55236758 | Design Group Id | 55236755 | Design Group Id | 55236756 | Design Group Id | 55236757 | Design Group Id | 55236758 |
| Intervention Id | 52136878 | Intervention Id | 52136878 | Intervention Id | 52136878 | Intervention Id | 52136878 | Intervention Id | 52136879 | Intervention Id | 52136879 | Intervention Id | 52136879 | Intervention Id | 52136879 |
Eligibilities
| Sequence: | 30556465 |
| Gender | All |
| Minimum Age | 18 Years |
| Maximum Age | N/A |
| Healthy Volunteers | Accepts Healthy Volunteers |
| Criteria | Inclusion Criteria: Healthy volunteers; OR, AMD, diabetic retinopathy, central serous chorioretinopathy, and/or glaucoma or glaucoma suspects or any other suspected eye disease Group-Specific Inclusion Criteria: — There are no group-specific inclusion criteria for patients with AMD, diabetic retinopathy, and central serous chorioretinopathy. Healthy Volunteers A normal clinical ophthalmic examination. Reliable VF, reproducible glaucoma hemifield tests labeled within normal limits on at least one test. Good quality (adequate signal strength ≥ 6/10, without segmentation algorithm failure and motion artifacts > 1 vessel diameter) RNFL and Ganglion Cell Inner Plexiform Layer (GCIPL) OCT, within normal limits. Primary Open Angle Glaucoma (POAG) Clinical characteristics of glaucoma: optic nerve head (ONH) abnormalities: global rim thinning, rim notch, or disc hemorrhage; retinal nerve fiber layer (RNFL) defect. Typical glaucomatous field loss in reliable VF, reproducible glaucoma hemifield tests labeled outside normal limits on at least two consecutive tests. Good quality (adequate signal strength ≥ 6/10, without segmentation algorithm failure and motion artifacts > 1 vessel diameter) RNFL and GCIPL OCT, labeled outside normal limits with typical glaucomatous RNFL and GCIL thinning. Normal Tension Glaucoma (NTG) Identical to POAG criteria with IOP recorded at ≤ 21 mmHg at any time point. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: – Any medical treatment (e.g., chronic corticosteroid, hydroxychloroquine, chloroquine, thioridazine, canthaxanthine) or conditions that affect VF (e.g., stroke) and retinal thickness other than glaucoma. |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254239259 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2023 |
| Actual Duration | 0 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | True |
| Minimum Age Num | 18 |
| Minimum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 3 |
| Number Of Secondary Outcomes To Measure | 2 |
Designs
| Sequence: | 30304794 |
| Allocation | Randomized |
| Intervention Model | Crossover Assignment |
| Observational Model | |
| Primary Purpose | Supportive Care |
| Time Perspective | |
| Masking | Double |
| Subject Masked | True |
| Investigator Masked | True |
Provided Documents
| Sequence: | 2569173 |
| Document Type | Informed Consent Form |
| Has Protocol | False |
| Has Icf | True |
| Has Sap | False |
| Document Date | 2023-04-11 |
| Url | https://ClinicalTrials.gov/ProvidedDocs/21/NCT05686421/ICF_000.pdf |
Responsible Parties
| Sequence: | 28683382 |
| Responsible Party Type | Sponsor |
Ipd Information Types
| Sequence: | 3314906 | Sequence: | 3314907 |
| Name | Study Protocol | Name | Statistical Analysis Plan (SAP) |