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

Recruiting

• Conditions: Neurotrophic Keratitis; Diabetic Retinopathy

• Registration Number: NCT05566717
• Lead Sponsor: Medical Center Ophthalmology Associates

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.

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-08-02
• Status Verified: 2022-09
• Primary Completion: 2022-09-30
• Study First Submitted QC: 2022-09-30
• Last Update Submitted: 2022-09-30
• Study First Posted: 2022-10-04
• Last Update Posted: 2022-10-04
• Study Completion: 2022-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medical Center Ophthalmology Associates; 🇺🇸 San Antonio, Texas, United States