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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-15

Study Completion Date

2022-03-23

Brief Summary

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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.

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Detailed Description

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Inclusion and Exclusion Criteria

The participant will be eligible to participate if the following criteria apply:

1. Written Informed Consent has been obtained prior to any study-related procedures
2. Male or female, 18 years of age and older prior to the initial visit
3. Established wearer of PROSE in the study eye with an optimized fit in the opinion of the clinician
4. 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
5. Initial PROSE fitting was initiated and completed at BostonSight, Needham
6. Current PROSE device does not have channels or fenestrations
7. 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
8. 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
9. In the opinion of the investigator, the subject has the ability to follow study instructions
10. 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:

1. Is currently participating in any other type of eye-related clinical or research study
2. Is pregnant or nursing as reported by the subject
3. 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
4. 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.

Conditions

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Keratoconus Ocular Surface Disease Pellucid Marginal Corneal Degeneration Ectasia Corneal Trauma Corneal Scar Dry Eye Syndromes Keratoconjunctivitis Sicca Sjogren's Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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study group

There is only one study group in this study. All subjects will receive the OCT scanning and PROSE lens fitting.

Group Type OTHER

Ocular surface optical coherence tomography

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Written Informed Consent has been obtained prior to any study-related procedures
2. Male or female, 18 years of age and older prior to the initial visit
3. Established wearer of PROSE in the study eye with an optimized fit in the opinion of the clinician
4. 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
5. Initial PROSE fitting was initiated and completed at BostonSight, Needham
6. Current PROSE device does not have channels or fenestrations
7. 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
8. 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
9. In the opinion of the investigator, the subject has the ability to follow study instructions
10. In the opinion of the investigator, the subject has the ability to complete all study procedures and visits

Exclusion Criteria

1. Is currently participating in any other type of eye-related clinical or research study
2. Is pregnant or nursing as reported by the subject
3. 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. -

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes