NCT02477605

Clinical Comparison of 27+® and 23-gauge ULTRAVIT® 7500 Cpm Vitrectomy Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the treatment day change between immediate postoperative and immediate preoperative intraocular pressure (IOP) between 27-gauge and 23-gauge vitrectomy instruments.

Detailed description

Required follow-up for this study is 3 months post treatment.

Conditions

• Vitreoretinal Disease

Interventions

Type	Name	Description
DEVICE	CONSTELLATION® 27-gauge Combined Surgical Pak	Sterile single-use supplies necessary to perform 1 vitrectomy surgery: 1 ULTRAVIT® 27-gauge 7500 cuts per minute (cpm) vitrectomy probe and a 27-gauge EDGEPLUS® Valved Entry System comprised of 3 trocar/cannulas and related accessories.
DEVICE	CONSTELLATION® 23-gauge Combined Surgical Pak	Sterile single-use supplies necessary to perform 1 vitrectomy surgery: 1 ULTRAVIT® 23-gauge 7500 cuts per minute (cpm) vitrectomy probe and a 23-gauge EDGEPLUS® trocar/cannula set comprising of 3 trocars/cannulas and related accessories.
PROCEDURE	Vitrectomy surgery	Microincisional pars plana vitrectomy (PPV) surgery for the treatment of various vitreoretinal diseases ranging from simple to advanced cases

Timeline

• Start date: 2015-07-16
• Primary completion: 2016-06-01
• Completion: 2016-08-31
• First posted: 2015-06-23
• Last updated: 2018-07-02
• Results posted: 2017-07-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study