Diabetic Retinopathy Clinical Trial
— AssessOfficial title:
An Investigator-Initiated Study to Assess the Association of Diabetic Retinopathy Severity Scale (DRSS) With Level of Decreased Corneal Sensitivity
NCT number | NCT05566717 |
Other study ID # | ASSESS |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2022 |
Est. completion date | October 31, 2022 |
Evaluate the association between level of decreased corneal sensitivity and diabetic retinopathy severity scale
Status | Recruiting |
Enrollment | 50 |
Est. completion date | October 31, 2022 |
Est. primary completion date | September 30, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Medical Center Ophthalmology Associates | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Medical Center Ophthalmology Associates | Oyster Point Pharma, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03660345 -
PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME
|
Phase 3 | |
Completed |
NCT03660371 -
ILM Peeling in PDR Patients Undergoing PPV for VH
|
N/A | |
Completed |
NCT03660384 -
Silicone Oil Versus Gas in PDR Patients Undergoing Vitrectomy
|
N/A | |
Completed |
NCT04905459 -
ARDA Software for the Detection of mtmDR
|
||
Active, not recruiting |
NCT04271709 -
Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT)
|
N/A | |
Recruiting |
NCT03713268 -
Intraoperative OCT Guidance of Intraocular Surgery II
|
||
Completed |
NCT05022615 -
Comparing 3 Imaging Systems
|
||
Completed |
NCT00385333 -
Metabolic Mapping to Measure Retinal Metabolism
|
Phase 2 | |
Recruiting |
NCT04101604 -
Biomarkers of Common Eye Diseases
|
||
Completed |
NCT03702374 -
Combined Antioxidant Therapy on Oxidative Stress, Mitochondrial Dysfunction Markers in Diabetic Retinopathy
|
Phase 3 | |
Completed |
NCT01908816 -
An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.
|
Phase 3 | |
Completed |
NCT04009980 -
Long-term Retinal Changes After Topical Citicoline Administration in Patients With Mild Signs of Diabetic Retinopathy in Type 1 Diabetes Mellitus.
|
N/A | |
Completed |
NCT02924311 -
Routine Clinical Practice for Use of Intravitreal Aflibercept Treatment in Patients With Diabetic Macular Edema
|
||
Not yet recruiting |
NCT06257082 -
Video-based Patient Education Intervention for Diabetic Eye Screening in Latinx Communities
|
N/A | |
Not yet recruiting |
NCT05452993 -
Screening for Diabetic Retinopathy in Pharmacies With Artificial Intelligence Enhanced Retinophotography
|
N/A | |
Withdrawn |
NCT02812030 -
Aflibercept for Retinopathy in the Real World
|
N/A | |
Completed |
NCT02391558 -
Clinical Evaluation of Noninvasive OCT Angiography Using a Zeiss OCT Prototype to Compare to Fluorescein Angiography
|
N/A | |
Active, not recruiting |
NCT02353923 -
OcuStem Nutritional Supplement in Diabetic Patients With Mild to Moderate Non-proliferative Retinopathy
|
N/A | |
Active, not recruiting |
NCT02330042 -
OCT Biomarkers for Diabetic Retinopathy
|
||
Completed |
NCT02390245 -
Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
|
N/A |