Clinical trial NCT05566717: An Investigator-Initiated Study to Assess the Association of Diabetic Retinopathy Severity Scale (DRSS) With Level of Decreased Corneal Sensitivity
Official title: An Investigator-Initiated Study to Assess the Association of Diabetic Retinopathy Severity Scale (DRSS) With Level of Decreased Corneal Sensitivity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Retinopathy
Neurotrophic Keratitis
Lead sponsor: Medical Center Ophthalmology Associates
Sponsor class: OTHER
Collaborators: name: Oyster Point Pharma, Inc.
First posted: 2022-10-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a single-center, controlled study to assess the association of diabetic retinopathy severity with reduction in corneal sensitivity in approximately 50 Type 1 and Type 2 diabetes subjects (100 eyes) at least 18 years of age and meeting all other study eligibility criteria.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Endpoint
timeFrame: 3months
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
Study officials:
References: