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An Investigator-Initiated Study to Assess the Association of Diabetic Retinopathy Severity Scale (DRSS) With Level of Decreased Corneal Sensitivity

Sponsor
Medical Center Ophthalmology Associates (Other)
Overall Status
Recruiting
CT.gov ID
NCT05566717
Collaborator
Oyster Point Pharma, Inc. (Industry)
50
Enrollment
1
Location
4
Anticipated Duration (Months)
12.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluate the association between level of decreased corneal sensitivity and diabetic retinopathy severity scale

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This study is assessing the association between neurotrophic keratopathy and diabetic retinopathy severity by examining subjects with diabetic retinopathy to associate DRSS and disease characteristics with corneal desensitization. In addition, to better understand the relationship of disease duration, HbA1c, and status of concurrent systemic therapies and diabetic retinopathy treatments, predictive modelling will be performed to determine predictive factors of patients at highest risk of developing reduced corneal sensitivity.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    An Investigator-Initiated Study to Assess the Association of Diabetic Retinopathy Severity Scale (DRSS) With Level of Decreased Corneal Sensitivity
    Actual Study Start Date :
    Jul 1, 2022
    Anticipated Primary Completion Date :
    Sep 30, 2022
    Anticipated Study Completion Date :
    Oct 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Primary Endpoint [3months]

      • To associate the Diabetic Retinopathy Severity Scale level 3 or higher (as confirmed by masked reading center) with the level of decreased corneal sensitivity in patients with Type 1 and Type 2 diabetes

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Have Type 1 or Type 2 diabetes with DRSS of 3 or higher

    • Be willing and able to sign the informed consent form (ICF)

    • Be at least 18 years of age

    • Be literate and able to complete questionnaires independently

    • Have provided verbal and written informed consent

    Exclusion Criteria:

    • Have a history of vitrectomy

    • Have a history of cornea, eyelid, glaucoma, or retina surgery

    • Have a history of previously diagnosed neurotrophic keratopathy or other cranial nerve V pathology, such as trigeminal neuralgia

    • Have a history of ocular herpes simplex virus infection

    • Have a history of herpes zoster ophthalmicus

    • Have a history of ocular chemical trauma

    • Have a history of underlying corneal dystrophies

    • Have had cataract surgery less than 3 months prior

    • Have a history of pan-retinal photocoagulation (PRP)

    • Have current Stage 2 or 3 neurotrophic keratopathy

    • Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject

    • Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to Visit 1

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical Center Ophthalmology Associates San Antonio Texas United States 78240

    Sponsors and Collaborators

    • Medical Center Ophthalmology Associates
    • Oyster Point Pharma, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Medical Center Ophthalmology Associates
    ClinicalTrials.gov Identifier:
    NCT05566717
    Other Study ID Numbers:
    • ASSESS
    First Posted:
    Oct 4, 2022
    Last Update Posted:
    Oct 4, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Retinal Diseases
    Diabetic Retinopathy
    Keratitis

    Study Results

    No Results Posted as of Oct 4, 2022