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| Name | Class |
|---|---|
| EYEdeal scanning, LTC | INDUSTRY |
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EYEdeal Scanning Technology enables rapid measurement of corneal and scleral topography. By accurately measuring the ocular surface with this imaging technology, the current iterative fitting method required to fit PROSE (prosthetic replacement of the ocular surface ecosystem) devices could be replaced and/or strengthened with a more rapid, automated fitting sequence. This could considerably reduce the time needed per visit, the number of visits, and the number of devices needed to be manufactured to reach the endpoint. Additionally, the scanning technology may afford the opportunity to successfully fit some pathology that were previously treatment failures. The automated technology may as well reduce the intensive clinician training time needed to fit PROSE devices, therefore increasing the availability and access to patients.
The goal of this research is to evaluate the reliability and efficacy of this automated technology for fitting PROSE devices. Data from real-time measurement of the human eye ocular surface topography will be used to fabricate a prosthetic lens. The fit of the PROSE device will be evaluated, as well as the subjective comfort of the fit.
Inclusion and Exclusion Criteria
The participant will be eligible to participate if the following criteria apply:
The participant would NOT be eligible to participate if at least one of the following criteria is met:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study group | Other | There is only one study group in this study. All subjects will receive the OCT scanning and PROSE lens fitting. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocular surface optical coherence tomography | Device | EYEdeal Scanning technology enables rapid measurement of the corneal and scleral topography which provides data for an automated sequence to fit PROSE devices |
| Measure | Description | Time Frame |
|---|---|---|
| Central Corneal Clearance | Central corneal clearance as measured by OCT after 45 minutes of lens wear Outcome measure reports data only from the study eye. | 45 minutes post lens application |
| Lens Decentration | Lens decentration after 45 minutes of lens wear (x axis) Outcome measure reports data only from the study eye. | 45 minutes post lens application |
| Lens Comfort After 45 Minutes of Lens Wear | 0 to 10 grading (0 = very comfortable to 10 = very uncomfortable) Outcome measure reports data only from the study eye. | 45 minutes post lens application |
| Number of Participants With Lens Centration | Each study eye (one eye from each participant) was evaluated to determine if the lens was "Centered" (yes) or "Decentered" (no) on the eye after 45 minutes of wear. Outcome measure reports data only from the study eye. All participants were reported in this outcome measure. | 45 minutes post lens application |
| Number of Participants With Aligned Scleral Landing Zone | Each study eye (one eye from each participant) was evaluated to determine if the scleral landing zone was properly aligned on the eye (yes) or not properly aligned on the eye (no) after 45 minutes of wear. Outcome measure reports data only from the study eye. All participants were reported in this outcome measure. | 45 minutes post lens application |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Rotation | Lens rotation after 45 minutes of wear. Lens rotation was measured using an embedded program in the iTRACE system. The rotation data with image guided fitting with the OCT system was collected to compare with known experience with non-image guided fitting sets (the traditional fitting process), which typically rotate approximately 20-30 degrees on the eye. A lower number may indicate the manufactured lens more closely approximates the contours of the eye. Outcome measure reports data only from the study eye. |
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Inclusion Criteria:
Exclusion Criteria:
45. Has had previous ocular surgery within the past 12 weeks
5. Intolerance to PROSE wear
6. Inability to maintain stable fixation and exposure for ocular surface imaging
7. Corneal touch by the posterior surface of the device in current PROSE device
8. Allergy to sodium fluorescein
9. Patient is an employee of BostonSight
10. Subject is currently incarcerated. -
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Brocks, MD | Boston Sight | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BostonSight | Needham | Massachusetts | 02494 | United States |
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Each participant contributed only one study eye for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group | OCT scanning and PROSE lens fitting based on scan data |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 14, 2020 | Oct 2, 2023 |
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| 45 minutes post lens application |
| Number of Participants Achieving an Acceptable Fitting Lens | Number of participants achieving an acceptable fitting lens after 45 minutes of lens wear. All participants are reported. Outcome measure reports data only from the study eye. Is the fit acceptable for dispensing to the patient (yes) or is the fit NOT acceptable for dispensing to patient (no) as evaluated 45 minutes post lens application. | 45 minutes post lens application |
| Number of Participants With Lens Movement | Number of patients with lens movement after 45 minutes of wear are reported. Lens movement (YES) means the lens is NOT appropriately fitting/settling on the eye. Lens movement (NO) means the lens is appropriately fitting/settling on eye. Outcome measure reports data only from the study eye. | 45 minutes |
| Number of Participants With Adequate Lens Limbal Clearance | Each study eye (one eye from each participant) was evaluated to determine if there was adequate (yes) lens limbal clearance or inadequate (no) lens limbal clearance after 45 minutes of wear. Outcome measure reports data only from the study eye. All participants were reported in this outcome measure. | 45 minutes post lens application |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Study Group | OCT scanning and PROSE lens fitting based on scan data |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Keratoconus | Keratoconus was determined by slit lamp examination. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Central Corneal Clearance | Central corneal clearance as measured by OCT after 45 minutes of lens wear Outcome measure reports data only from the study eye. | Posted | Mean | Standard Error | microns | 45 minutes post lens application |
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| ||||||||||||||||||||||||||
| Primary | Lens Decentration | Lens decentration after 45 minutes of lens wear (x axis) Outcome measure reports data only from the study eye. | Posted | Mean | Standard Deviation | microns | 45 minutes post lens application |
|
| |||||||||||||||||||||||||||
| Primary | Lens Comfort After 45 Minutes of Lens Wear | 0 to 10 grading (0 = very comfortable to 10 = very uncomfortable) Outcome measure reports data only from the study eye. | Posted | Mean | Standard Deviation | units on a scale | 45 minutes post lens application |
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| |||||||||||||||||||||||||||
| Primary | Number of Participants With Lens Centration | Each study eye (one eye from each participant) was evaluated to determine if the lens was "Centered" (yes) or "Decentered" (no) on the eye after 45 minutes of wear. Outcome measure reports data only from the study eye. All participants were reported in this outcome measure. | Posted | Count of Participants | Participants | 45 minutes post lens application |
|
| ||||||||||||||||||||||||||||
| Primary | Number of Participants With Aligned Scleral Landing Zone | Each study eye (one eye from each participant) was evaluated to determine if the scleral landing zone was properly aligned on the eye (yes) or not properly aligned on the eye (no) after 45 minutes of wear. Outcome measure reports data only from the study eye. All participants were reported in this outcome measure. | Posted | Count of Participants | Participants | 45 minutes post lens application |
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| Secondary | Lens Rotation | Lens rotation after 45 minutes of wear. Lens rotation was measured using an embedded program in the iTRACE system. The rotation data with image guided fitting with the OCT system was collected to compare with known experience with non-image guided fitting sets (the traditional fitting process), which typically rotate approximately 20-30 degrees on the eye. A lower number may indicate the manufactured lens more closely approximates the contours of the eye. Outcome measure reports data only from the study eye. | Posted | Mean | Standard Deviation | degrees | 45 minutes post lens application |
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| Secondary | Number of Participants Achieving an Acceptable Fitting Lens | Number of participants achieving an acceptable fitting lens after 45 minutes of lens wear. All participants are reported. Outcome measure reports data only from the study eye. Is the fit acceptable for dispensing to the patient (yes) or is the fit NOT acceptable for dispensing to patient (no) as evaluated 45 minutes post lens application. | Posted | Count of Participants | Participants | 45 minutes post lens application |
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| Secondary | Number of Participants With Lens Movement | Number of patients with lens movement after 45 minutes of wear are reported. Lens movement (YES) means the lens is NOT appropriately fitting/settling on the eye. Lens movement (NO) means the lens is appropriately fitting/settling on eye. Outcome measure reports data only from the study eye. | Posted | Count of Participants | Participants | 45 minutes |
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| Secondary | Number of Participants With Adequate Lens Limbal Clearance | Each study eye (one eye from each participant) was evaluated to determine if there was adequate (yes) lens limbal clearance or inadequate (no) lens limbal clearance after 45 minutes of wear. Outcome measure reports data only from the study eye. All participants were reported in this outcome measure. | Posted | Count of Participants | Participants | 45 minutes post lens application |
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1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Group | There is only one study group in this study. All subjects will receive the OCT scanning and PROSE lens fitting based on the scan. | 0 | 10 | 0 | 10 | 0 | 10 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Brocks, MD | BostonSight | (781)726-7337 | ecrowley@bostonsight.org |
| Prot_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 14, 2020 | Oct 2, 2023 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| D004108 | Dilatation, Pathologic |
| D065306 | Corneal Injuries |
| D015352 | Dry Eye Syndromes |
| D007638 | Keratoconjunctivitis Sicca |
| D012859 | Sjogren's Syndrome |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005131 | Eye Injuries |
| D005151 | Facial Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D007766 | Lacrimal Apparatus Diseases |
| D007637 | Keratoconjunctivitis |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D007634 | Keratitis |
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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