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

September 30, 2022 updated by: Medical Center Ophthalmology Associates
Evaluate the association between level of decreased corneal sensitivity and diabetic retinopathy severity scale

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Endpoint
Time Frame: 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
3months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Center Ophthalmology Associates

Collaborators

Oyster Point Pharma, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

October 31, 2022

Study Registration Dates

First Submitted

August 2, 2022

First Submitted That Met QC Criteria

September 30, 2022

First Posted (Actual)

October 4, 2022

Study Record Updates

Last Update Posted (Actual)

October 4, 2022

Last Update Submitted That Met QC Criteria

September 30, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASSESS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

IPD will not be shared however demographics and baseline characteristics will be summarized.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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