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Age: 18Years +
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ID05844384

Evaluating Nanodropper Device Versus Standard Eye Drops for Lowering Eye Pressure in Adults with Primary Open-Angle Glaucoma or Ocular Hypertension

Led by 59th Medical Wing · Updated on 2023-05-06

30

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of using Nanodropper-mediated microdrops of eye pressure-lowering medications compared to standard full-volume eyedrops in patients with primary open-angle glaucoma POAG and ocular hypertension OHTN. This randomized, single-masked crossover trial aims to see if the smaller drops delivered by Nanodropper affect intraocular pressure IOP differently than regular drops over time. Participants will use two different delivery methods during the study. One group starts with Nanodropper microdrops daily for three months followed by a three-month period using standard eyedrops, while the other group begins with standard drops and then switches to Nanodropper. Patients will have safety checks one month after starting Nanodropper use and clinical assessments at three and six months. During the study, participants will have their eye pressure measured to track changes from baseline to six months. Additional tests include visual acuity, retinal nerve fiber layer thickness, and visual field assessments. Patients will also complete surveys about side effects and ease of use. The total participation lasts six months with several follow-up visits to monitor safety and effectiveness.

CONDITIONS

Brief Title

Nanodropper Use in Primary Open-Angle Glaucoma Patients: A Non-Inferiority Trial

Research Team

J

Jose E Capo-Aponte, OD, PhD

J

Jennifer Steger, PhD

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