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

NCT04649177 | Completed Results FDA Device

• 1 other identifier: BFS-OCT-01
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  45 minutes post lens application

Secondary Outcomes (4)

• Lens Rotation

  45 minutes post lens application

• Number of Participants Achieving an Acceptable Fitting Lens

  45 minutes post lens application

• Number of Participants With Lens Movement

  45 minutes

• Number of Participants With Adequate Lens Limbal Clearance

  45 minutes post lens application

Study Arms (1)

study group

OTHER

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

Interventions

Ocular surface optical coherence tomography DEVICE

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

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Boston Sight: lead
• EYEdeal scanning, LTC: collaborator

Study Sites (1)

BostonSight

Needham, Massachusetts, 02494, United States

Location

MeSH Terms

Conditions

Keratoconus; Dilatation, Pathologic; Corneal Injuries; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Eye Injuries; Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Daniel Brocks, MD
• Organization: BostonSight

ecrowley@bostonsight.org

(781)726-7337

Study Officials

• Daniel Brocks, MD

  Boston Sight

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Medical Officer

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: December 2, 2020
• Study Start: December 15, 2020
• Primary Completion: March 23, 2022
• Study Completion: March 23, 2022
• Last Updated: October 27, 2023
• Results First Posted: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)