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

NCT05566717 | Unknown

• 1 other identifier: ASSESS
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Retinopathy; Neurotrophic Keratitis

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical Center Ophthalmology Associates: lead
• Oyster Point Pharma, Inc.: collaborator

Study Sites (1)

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

Lolita Kirschbaum

CONTACT

2106972006; lkirschbaum@mcoaeyecare.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: October 4, 2022
• Study Start: July 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: October 31, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)