- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04649177
Pilot Study to Investigate the Feasibility, Reliability and Efficacy of Utilizing OCT to Automate PROSE Fitting
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Inclusion and Exclusion Criteria
The participant will be eligible to participate if the following criteria apply:
- Written Informed Consent has been obtained prior to any study-related procedures
- Male or female, 18 years of age and older prior to the initial visit
- Established wearer of PROSE in the study eye with an optimized fit in the opinion of the clinician
- No medical need for a PROSE retreatment or replacement lens at the time of enrollment in the study eye, in the opinion of the clinician
- Initial PROSE fitting was initiated and completed at BostonSight, Needham
- Current PROSE device does not have channels or fenestrations
- Currently wears a PROSE device in the study eye primarily for an irregular ocular surface /irregular cornea (including but not limited to Keratoconus, Pellucid Marginal Degeneration, Ectasia, Post-Penetrating Keratoplasty, Corneal Scar, Trauma) AND/OR ocular surface disease
- Has the ability to NOT wear the current PROSE device in the study eye for 3 days prior to scan and 3 days prior to first fitting appointment in the opinion of the investigator and subject
- In the opinion of the investigator, the subject has the ability to follow study instructions
- In the opinion of the investigator, the subject has the ability to complete all study procedures and visits
The participant would NOT be eligible to participate if at least one of the following criteria is met:
- Is currently participating in any other type of eye-related clinical or research study
- Is pregnant or nursing as reported by the subject
- Has a condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound study outcomes, or may significantly interfere with the subject's participation in the study
- Has had previous ocular surgery within the past 12 weeks
- Intolerance to PROSE wear
- Inability to maintain stable fixation and exposure for ocular surface imaging
- Corneal touch by the posterior surface of the device in current PROSE device
- Allergy to sodium fluorescein
- Patient is an employee of BostonSight
- Subject is currently incarcerated.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Needham, Massachusetts, United States, 02494
- BostonSight
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Written Informed Consent has been obtained prior to any study-related procedures
- Male or female, 18 years of age and older prior to the initial visit
- Established wearer of PROSE in the study eye with an optimized fit in the opinion of the clinician
- No medical need for a PROSE retreatment or replacement lens at the time of enrollment in the study eye, in the opinion of the clinician
- Initial PROSE fitting was initiated and completed at BostonSight, Needham
- Current PROSE device does not have channels or fenestrations
- Currently wears a PROSE device in the study eye primarily for an irregular ocular surface /irregular cornea (including but not limited to Keratoconus, Pellucid Marginal Degeneration, Ectasia, Post-Penetrating Keratoplasty, Corneal Scar, Trauma) AND/OR ocular surface disease
- Has the ability to NOT wear the current PROSE device in the study eye for 3 days prior to scan and 3 days prior to first fitting appointment in the opinion of the investigator and subject
- In the opinion of the investigator, the subject has the ability to follow study instructions
- In the opinion of the investigator, the subject has the ability to complete all study procedures and visits
Exclusion Criteria:
- Is currently participating in any other type of eye-related clinical or research study
- Is pregnant or nursing as reported by the subject
- Has a condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound study outcomes, or may significantly interfere with the subject's participation in the study
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. -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: study group
There is only one study group in this study.
All subjects will receive the OCT scanning and PROSE lens fitting.
|
EYEdeal Scanning technology enables rapid measurement of the corneal and scleral topography which provides data for an automated sequence to fit PROSE devices
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Central Corneal Clearance
Time Frame: 45 minutes post lens application
|
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
Time Frame: 45 minutes post lens application
|
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
Time Frame: 45 minutes post lens application
|
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
Time Frame: 45 minutes post lens application
|
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
Time Frame: 45 minutes post lens application
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lens Rotation
Time Frame: 45 minutes post lens application
|
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. |
45 minutes post lens application
|
Number of Participants Achieving an Acceptable Fitting Lens
Time Frame: 45 minutes post lens application
|
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
Time Frame: 45 minutes
|
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
Time Frame: 45 minutes post lens application
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Daniel Brocks, MD, Boston Sight
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Autoimmune Diseases
- Eye Diseases
- Wounds and Injuries
- Disease
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Stomatognathic Diseases
- Mouth Diseases
- Craniocerebral Trauma
- Trauma, Nervous System
- Lacrimal Apparatus Diseases
- Conjunctivitis
- Conjunctival Diseases
- Keratitis
- Corneal Diseases
- Arthritis, Rheumatoid
- Xerostomia
- Salivary Gland Diseases
- Facial Injuries
- Eye Injuries
- Syndrome
- Dry Eye Syndromes
- Keratoconjunctivitis Sicca
- Keratoconus
- Sjogren's Syndrome
- Keratoconjunctivitis
- Corneal Injuries
Other Study ID Numbers
- BFS-OCT-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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