KeratoconusNCT04649177
Pilot Study to Investigate the Feasibility, Reliability and Efficacy of Utilizing OCT to Automate PROSE Fitting
A study testing Ocular surface optical coherence tomography in people with Keratoconus and Ocular Surface Disease, run by Boston Sight at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keratoconus, Ocular Surface Disease, Pellucid Marginal Corneal Degeneration
- What is being tested?
- Ocular surface optical coherence tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2020to 23 Mar 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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. -
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Keratoconus, Ocular Surface Disease, Pellucid Marginal Corneal Degeneration, Ectasia, Corneal Trauma, Corneal Scar
- Being tested
- Ocular surface optical coherence tomography
- Medical subject headings
- Keratoconus, Dilatation, Pathologic, Corneal Injuries, Dry Eye Syndromes, Keratoconjunctivitis Sicca, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocular surface optical coherence tomographyDevice
EYEdeal Scanning technology enables rapid measurement of the corneal and scleral topography which provides data for an automated sequence to fit PROSE devices
| Study group | Role | What they receive |
|---|---|---|
| study group | Other | There is only one study group in this study. All subjects will receive the OCT scanning and PROSE lens fitting. Receives: Device: Ocular surface optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 45 minutes post lens application
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 45 minutes post lens application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start15 Dec 2020
- Primary completion23 Mar 2022
- Study completion23 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for KeratoconusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Sight
- Sponsor type
- University, hospital or other
- Collaborators
- EYEdeal scanning, LTC
- Responsible party
- Principal investigator, Daniel C Brocks, Boston Sight
- Investigators
- Daniel Brocks, MD, Principal investigator, Boston Sight
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649177
- Sponsor's protocol ID
- BFS-OCT-01
- Status last verified
- Oct 2023
- First submitted
- 13 Nov 2020
- Last updated
- 27 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Investigate the Feasibility, Reliability and Efficacy of Utilizing OCT to Automate PROSE Fitting
- ClinicalTrials.gov ID
- NCT04649177
- Acronym / sponsor ID
- BFS-OCT-01
- Conditions
- Keratoconus, Ocular Surface Disease, Pellucid Marginal Corneal Degeneration, Ectasia, Corneal Trauma, Corneal Scar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Boston SightUniversity, hospital or other
- Collaborators
- EYEdeal scanning, LTC
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 23 Mar 2022 (actual)
- Study completion
- 23 Mar 2022 (actual)
- First posted
- 2 Dec 2020 (actual)
- Results
- Posted 27 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | Other | Device: Ocular surface optical coherence tomographyThere is only one study group in this study. All subjects will receive the OCT scanning and PROSE lens fitting. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ocular surface optical coherence tomographyEYEdeal Scanning technology enables rapid measurement of the corneal and scleral topography which provides data for an automated sequence to fit PROSE devices | Device | study group |
Primary outcome
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.
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.
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.
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.
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.
4 secondary outcomes
Lens Rotation
Time frame: 45 minutes post lens application
Number of Participants Achieving an Acceptable Fitting Lens
Time frame: 45 minutes post lens application
Number of Participants With Lens Movement
Time frame: 45 minutes
Number of Participants With Adequate Lens Limbal Clearance
Time frame: 45 minutes post lens application
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Daniel Brocks, MD principal investigator
Boston Sight
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ocular surface optical coherence tomography in people with Keratoconus and Ocular Surface Disease, run by Boston Sight 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 10 inclusion and 10 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 27 Oct 2023. 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?
Yes. Results are posted in the registry (first posted 27 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Central Corneal Clearance (time frame: 45 minutes post lens application). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2023.