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

Alcon

Status: Completed

Conditions: Vitreoretinal Disease

Treatments: Device: CONSTELLATION® 27-gauge Combined Surgical Pak; Device: CONSTELLATION® 23-gauge Combined Surgical Pak; Procedure: Vitrectomy surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT02477605

VRH172-P001

Details and patient eligibility

About

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.

Full description

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

Enrollment: 137 patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willing and able to provide informed consent and attend all required study visits;
• Requires vitrectomy in at least one eye;
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Previous vitrectomy or glaucoma surgery;
• Planned treatment requires scleral buckling, combined procedures (eg, cataract surgery), silicone oil, and expansive gas other than sterile air;
• Treated with topical IOP lowering medication(s) at any time from baseline assessment to time of surgery;
• Pregnant or planning to become pregnant during the course of the trial;
• Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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137 participants in 2 patient groups

27-gauge pak

Experimental group

Description:

CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery

Treatment:

Procedure: Vitrectomy surgery

Device: CONSTELLATION® 27-gauge Combined Surgical Pak

23-gauge pak

Active Comparator group

Description:

CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery

Treatment:

Procedure: Vitrectomy surgery

Device: CONSTELLATION® 23-gauge Combined Surgical Pak