NCT03647267

Effects of Pneumatic Vitreolysis on Vitreomacular Traction

Randomized Clinical Trial Assessing the Effects of Pneumatic Vitreolysis on Vitreomacular Traction

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Jaeb Center for Health Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Eyes with idiopathic symptomatic vitreomacular traction (VMT) without a macular hole will be randomly assigned to 0.3-mL intraocular gas (C3F8) injection or sham injection to determine if pneumatic vitreolysis (PVL) is effective in releasing VMT.

Detailed description

Investigational Device: 0.3-mL intraocular gas (C3F8) injection Objectives Primary 1. To compare the proportion of eyes with central VMT release on OCT after pneumatic vitreolysis with gas injection versus observation (sham injection) in eyes with VMT without an associated macular hole. Secondary 2. To evaluate visual function outcomes at 24 weeks after gas injection is performed compared with sham injection. Study Design: Multi-center, randomized clinical trial

Conditions

• Vitreomacular Traction

Interventions

Type	Name	Description
DEVICE	Pneumatic Vitreolysis (C3F8 injection)	Pneumatic Vitreolysis will be performed via an intraocular injection of C3F8 gas. Perfluoropropane (C3F8) is an inert gas under pressure and is administered by injection into the vitreous cavity. It was approved by the FDA in February 1993 (P900066) for the use of placing pressure on detached retina.
OTHER	Observation	No intervention; sham injection only

Timeline

• Start date: 2018-10-16
• Primary completion: 2020-08-06
• Completion: 2020-08-06
• First posted: 2018-08-27
• Last updated: 2022-09-21
• Results posted: 2021-10-28

Locations

41 sites across 1 country: United States

Regulatory

• FDA-regulated device study