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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04649177

Enrollment

Registered

2020-12-02

Start date

2020-12-15

Completion date

2022-03-23

Last updated

2023-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Detailed description

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.

Interventions

DEVICEOcular 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Yes

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. -

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Aligned Scleral Landing Zone	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.
Central Corneal Clearance	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	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	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	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.

Secondary

Measure	Time frame	Description
Number of Participants Achieving an Acceptable Fitting Lens	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.
Number of Participants With Lens Movement	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.
Number of Participants With Adequate Lens Limbal Clearance	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.
Lens Rotation	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.

Countries

United States

Participant flow

Pre-assignment details

Each participant contributed only one study eye for this study.

Participants by arm

Arm	Count
Study Group OCT scanning and PROSE lens fitting based on scan data	10
Total	10

Baseline characteristics

Characteristic	Study Group	—
Age, Continuous	58 years STANDARD_DEVIATION 11.84	—
Keratoconus	10 Participants	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment United States	10 participants	—
Sex: Female, Male Female	4 Participants	—
Sex: Female, Male Male	6 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 10
other Total, other adverse events	0 / 10
serious Total, serious adverse events	0 / 10

Outcome results

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.