Phase 4
N=47
Nailfold Capillary Blood Flow With Latanoprost Bunod
Glaucoma, Open-Angle
Bottom Line
View on ClinicalTrials.gov: NCT03949244 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: NFC Blood Flow at Baseline and 15 Minutes — 72.52; 83.94; 93.01; 60.50 pL/s
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Latanoprost 0.005% (Drug); Latanoprost bunod 0.024% (Drug); Normal saline 0.9% (Drug); Nailfold capillaroscopy (Diagnostic_test)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY NFC Blood Flow at Baseline and 15 Minutes |
72.52; 83.94; 93.01; 60.50; 75.57; 69.70 | — |
Summary
The purpose of this study is to look at the relationship of small blood vessels irregularities observed with an imaging system called video nailfold capillaroscopy in people with primary open-angle glaucoma. Nailfold capillaroscopy (NFC) is a video camera with a magnifying lens used for studying the movement of blood in small blood vessels. It is simple, safe and does not penetrate the skin. The skin fold that is at the tip of the finger is called the "nailfold". NFC has been used to assess blood vessel narrowing in patients with glaucoma.
Eligibility Criteria
Inclusion Criteria
- 40 years old to 80 years old
- All participants will have open angles and no signs of secondary glaucoma such as exfoliation syndrome
- Untreated intraocular pressure (IOP) may be ≤ 21mmHg or ≥ 21mmHg in both eyes
- The cup-to-disc ratio (CDR) ≥ 0.6 in both eyes and CDR asymmetry ≤ 0.2.
- POAG patients will have reliable Humphrey Visual Field (HVF) loss consistent with optic nerve damage
- POAG patients can have any stage of POAG and be on any form of treatment for their disease.
- Willingness to sign informed consent and comply with study procedures.
Exclusion Criteria
- History of non-POAG forms of glaucoma
- Pregnancy
- Inability to give informed consent
Data sourced from ClinicalTrials.gov (NCT03949244). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.