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The 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
Brief Summary:
Evaluate the association between level of decreased corneal sensitivity and diabetic retinopathy severity scale
| Diabetic Retinopathy Neurotrophic Keratitis |
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 |
| 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 |
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study:  | 18 Years and older  (Adult, Older Adult) |
| Sexes Eligible for Study: Â | All |
| Sampling Method: Â | 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05566717
| Medical Center Ophthalmology Associates | |
| San Antonio, Texas, United States, 78240 | |
| Contact: Lolita Kirschbaum   210-697-2020   lkirschbaum@mcoaeyecare.com   | |
| Contact     msinger@mcoaeyecare.com   | |
| Principal Investigator: Michael A Singer, MD Â Â Â Â Â Â | |
Medical Center Ophthalmology Associates
Oyster Point Pharma, Inc.
| Responsible Party: | Medical Center Ophthalmology Associates |
| ClinicalTrials.gov Identifier: | NCT05566717 Â Â |
| Other Study ID Numbers: | ASSESS |
| First Posted: | October 4, 2022 Â Â 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
| 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.
