Recruiting

Observational Study

Sponsor:

Medical Center Ophthalmology Associates

Code:

NCT05566717

Conditions

Diabetic Retinopathy

Neurotrophic Keratitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Conditions

Diabetic Retinopathy

Neurotrophic Keratitis

Study ID

NCT05566717

Start date

Jul 1, 2022

Status verified date

Sep, 2022

Completion date

Oct 31, 2022

Anticipated

Primary completion date

Sep 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Primary Endpoint [ Time Frame: 3months ]

Central Contacts and Locations

Central contacts

Lolita Kirschbaum

2106972006lkirschbaum@mcoaeyecare.com

Locations

Medical Center Ophthalmology Associates

Recruiting

San Antonio, Texas, United States, 78240

Contacts

Lolita Kirschbaum

210-697-2020lkirschbaum@mcoaeyecare.com

msinger@mcoaeyecare.com

Principal Investigator:

Michael A Singer, MD

More Information

Sponsor

Medical Center Ophthalmology Associates

Last update posted

Oct 4, 2022

Last verified

Sep, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Medical Center Ophthalmology Associates on 2022-10-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.