Diabetic Retinopathy Clinical Trial
— AssessOfficial title:
An Investigator-Initiated Study to Assess the Association of Diabetic Retinopathy Severity Scale (DRSS) With Level of Decreased Corneal Sensitivity
NCT number | NCT05566717 |
Other study ID # | ASSESS |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2022 |
Est. completion date | October 31, 2022 |
Evaluate the association between level of decreased corneal sensitivity and diabetic retinopathy severity scale
Status | Recruiting |
Enrollment | 50 |
Est. completion date | October 31, 2022 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Medical Center Ophthalmology Associates | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Medical Center Ophthalmology Associates | Oyster Point Pharma, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Endpoint | • 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 | 3months |
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