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

NCT ID: NCT05566717

Last Updated: 2022-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2022-10-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetic Retinopathy Neurotrophic Keratitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oyster Point Pharma, Inc.

INDUSTRY

Sponsor Role collaborator

Medical Center Ophthalmology Associates

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical Center Ophthalmology Associates

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lolita Kirschbaum

Role: CONTACT

2106972006

Facility Contacts

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Lolita Kirschbaum

Role: primary

210-697-2020

Role: backup

Other Identifiers

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ASSESS

Identifier Type: -

Identifier Source: org_study_id

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