Ophthalmology Clinical Trials

(Updated 4/10/14)

Contact Eliza Dubose at (919) 595-9534, Megha Karmalkar at (919) 595-9534, or Sandy Barnhart, MPH at (919) 843-0076 for details regarding clinical trials in the UNC Department of Ophthalmology.


Cornea Clinical Trials - Ongoing Recruitment

Dry Eye/Reliability and Validity of the Dry Eye Symptom Severity Score (PI: Davis)

108 patients with dry eye and 50 control subjects are needed.  Patients will be asked to complete two symptom questionnaires, the Dry Eye Symptom Severity Score (DESSS) and the Ocular Surface Disease Index (OSDI), and participate in an exam of the cornea.  There will be a two week follow-up, at which point the DESSS will be completed for repeat reliability.


Glaucoma Clinical Trials - Ongoing Recruitment

Pilot Study on Ambulatory Intraocular Pressure and Blood Pressure Monitoring in Glaucoma (PI: Mwanza)

This is a 24 hour study to measure blood pressure and eye pressure.  Patients will be expected to wear both devices for the full 24 hours, and return it to the clinic the following day.  20 patients will be recruited through Family Medicine, and 20 patients will be recruited through the UNC Kittner Eye Center Glaucoma clinic.

Primary Open Angle Glaucoma / Bausch & Lomb 770 LUNAR Study (PI: Lawrence)

This is a 6 month study evaluating whether or not the use of an investigational drug used once daily is as effective as the standard use of Timolol.  There will be 2 phases, a 3 month efficacy phase (after an initial washout) followed by a 3 month open-label safety phase.  Participants must have an IOP between 26 and 32 after washout.


Neuro-Ophthalmology Clinical Trials - Ongoing Recruitment

None currently


Oculoplastics Clinical Trials - Ongoing Recruitment

None currently


Pediatric Clinical Trials - Ongoing Recruitment

Retinopathy of Prematurity / Hand-Held Spectral Domain Optical Coherence Tomography Imaging of Infant Eyes (PI: Cabrera)

In this study we are recruiting primarily premature infants to image the retina and optic nerve in order to better understand normal ocular development in this population as well as abnormal development (particularly in retinopathy of prematurity). The study is expected to last approximately 2 years.


Retina Clinical Trials - Ongoing Recruitment

Diabetic Macular Edema / Diabetic Retinopathy Clinical Research Network (PI: Garg)

DRCR V: Treatment for Central-Involved Diabetic Macular Edema in Eyes with Very Good Visual Acuity

This is a 2 year study comparing laser, observation, and injections for treatment of Diabetic Macular Edema in patients with vision of 20/25 or better.  Patients will be randomly assigned to one of the three groups for the duration of the study.

Retinal Vein Occlusion / Ambulatory Blood Pressure Trends in Patients with Retinal Vein Occlusion: A Preliminary Study (PI: Chavala)

This is a 24 hour study to measure blood pressure and stroke risk factors.  Patients will be expected to wear a blood pressure monitoring device for the full 24 hours, and return it to the clinic the following day. 


Studies In Progress (no longer enrolling):

Diabetic Macular Edema / Diabetic Retinopathy Clinical Research Network (PI: Garg)

DRCR M: Effect of Diabetes Education during Retinal Opthalmology Visits on Diabetes Control

This study is to assess whether glycemic control (assessed with HbA1c measurement) in individuals with type 1 or type 2 diabetes can be improved with a point-of-care measurement of HbA1c in the ophthalmologist’s office combined with a personalized risk assessment for diabetic retinopathy and other complications of diabetes.

DRCR T: A Comparative Effectiveness Study of Intravitreal Aflibercept, Bevacizumab and Ranibizumab for Diabetic Macular Edema

This is a 2 year study comparing Aflibercept (Eylea), Bevacizumab (Avastin), and Ranibizumab (Lucentis) for treatment of Diabetic Macular Edema.  Patients will be randomly assigned to receive one of the three drugs for the duration of the study.

 

Age-Related Macular Degeneration / CATT Follow-up Study (PI: Meredith)

This is a single follow-up visit for original participants in the CATT trial.

 

Primary Open Angle Glaucoma / FSV5-002 (PI: Budenz)

This is a 6 month study evaluating the effectiveness of an ocular insert to deliver Bimatoprost compared to the standard use of Timolol.  Participants must be on monotherapy and have an IOP of 23 or greater after a 28 day washout period.  

 

Primary Open Angle Glaucoma / Alcon M-13-020 (PI: Lawrence)

This is 6 week study to evaluate the addition of Simbrinza to patients that are currently using either Travatan, Xalatan, or Lumigan after an initial washout period.  Patients must have an IOP between 21 and 32 after washout.