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

An Investigator-Initiated Study to Assess the Association of Diabetic Retinopathy Severity Scale (DRSS) With Level of Decreased Corneal Sensitivity
warningThe safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05566717
Recruitment Status : **RECRUITING NOW**

First Posted : October 4, 2022

Last Update Posted : October 4, 2022

Sponsor:

Collaborator:

Information provided by (Responsible Party):

Medical Center Ophthalmology Associates

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Study Type :Observational
Estimated Enrollment :50 participants
Observational Model:Case-Only
Time Perspective:Cross-Sectional
Official Title:An Investigator-Initiated Study to Assess the Association of Diabetic Retinopathy Severity Scale (DRSS) With Level of Decreased Corneal Sensitivity
Actual Study Start Date :July 1, 2022
Estimated Primary Completion Date :September 30, 2022
Estimated Study Completion Date :October 31, 2022

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Ages Eligible for Study:  18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:  All
Sampling Method:  Non-Probability Sample

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.

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

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Responsible Party:Medical Center Ophthalmology Associates
ClinicalTrials.gov Identifier:NCT05566717    
Other Study ID Numbers:ASSESS
First Posted:October 4, 2022    Key Record Dates
Last Update Posted:October 4, 2022
Last Verified:September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:No
Plan Description:IPD will not be shared however demographics and baseline characteristics will be summarized.

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Studies a U.S. FDA-regulated Drug Product:No
Studies a U.S. FDA-regulated Device Product:No

Additional relevant MeSH terms:

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Retinal Diseases
Diabetic Retinopathy
Keratitis
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Corneal Diseases

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

October 5, 2022Comments OffClinicalTrials.gov | Endocrinology Clinical Trials | Endocrinology Studies | US National Library of Medicine
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