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

Diabetic Retinopathy Clinical Trial

— Assess  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05566717
• Other study ID #: ASSESS
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: October 31, 2022

Study information

• Verified date: September 2022
• Source: Medical Center Ophthalmology Associates
• Contact: Lolita Kirschbaum
• Phone: 2106972006
• Email: lkirschbaum[@]mcoaeyecare.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 31, 2022
• Est. primary completion date: September 30, 2022
• 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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Keratitis
• Neurotrophic Keratitis
• Retinal Diseases

Locations

Country	Name	City	State
United States	Medical Center Ophthalmology Associates	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Medical Center Ophthalmology Associates	Oyster Point Pharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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