Pilot Study to Investigate the Feasibility, Reliability and Efficacy of Utilizing OCT to Automate PROSE Fitting

Sponsor

Boston Sight (Other)

Overall Status

Completed

CT.gov ID

NCT04649177

Collaborator

EYEdeal scanning, LTC (Other)

Enrollment

Location

Arm

15.2

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Keratoconus Ocular Surface Disease Pellucid Marginal Corneal Degeneration Ectasia Corneal Trauma Corneal Scar Dry Eye Syndromes Keratoconjunctivitis Sicca Sjogren's Syndrome	Device: Ocular surface optical coherence tomography	N/A

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

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pilot Study to Investigate the Feasibility, Reliability and Efficacy of Utilizing OCT to Automate PROSE Fitting

Actual Study Start Date :

Dec 15, 2020

Actual Primary Completion Date :

Mar 23, 2022

Actual Study Completion Date :

Mar 23, 2022

Arms and Interventions

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.	Device: Ocular surface optical coherence tomography EYEdeal Scanning technology enables rapid measurement of the corneal and scleral topography which provides data for an automated sequence to fit PROSE devices

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.

Device: Ocular surface optical coherence tomography

EYEdeal Scanning technology enables rapid measurement of the corneal and scleral topography which provides data for an automated sequence to fit PROSE devices

Outcome Measures

Primary Outcome Measures

Central Corneal Clearance [45 minutes post lens application]
microns
Lens decentration [45 minutes post lens application]
microns
Lens comfort [45 minutes post lens application]
0 to 10 grading
Lens centration [45 minutes post lens application]
centered/decentered
Scleral landing zone [45 minutes post lens application]
aligned/impingement/edge lift

Secondary Outcome Measures

Lens rotation [45 minutes post lens application]
degrees
Acceptable fitting lens [45 minutes post lens application]
yes/no
Lens movement [45 minutes]
none/minimal/excessive
Lens limbal clearance [45 minutes post lens application]
inadequate/adequate/excessive

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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
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. -