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

Summary

Participation Requirements

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 s...

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.

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