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

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.

Study Overview

• Status: Completed
• Conditions: Vitreoretinal Disease
• Intervention / Treatment: Device: CONSTELLATION® 27-gauge Combined Surgical Pak; Procedure: Vitrectomy surgery; Device: CONSTELLATION® 23-gauge Combined Surgical Pak

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Contact Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 27-gauge pak; CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery	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.; Procedure: Vitrectomy surgery; Microincisional pars plana vitrectomy (PPV) surgery for the treatment of various vitreoretinal diseases ranging from simple to advanced cases
Active Comparator: 23-gauge pak; CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery	Procedure: Vitrectomy surgery; Microincisional pars plana vitrectomy (PPV) surgery for the treatment of various vitreoretinal diseases ranging from simple to advanced cases; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Intraocular Pressure (IOP) on Operative Day	IOP (fluid pressure inside the eye) was assessed using the study specified tono-pen and measured in millimeters of mercury (mmHg). Change was defined as the difference between immediate postoperative IOP and immediate preoperative IOP. A greater change in IOP may indicate a less stable posterior chamber and/or a more invasive surgery.	Day 0 preoperative, Day 0 postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Conjunctival Edema Score at Week 1	Conjunctival edema (swelling) was assessed during examination by the investigator and graded on a scale of 0-3, where 0=Absent and 3=Severe. Each sclerotomy wound was graded as infusion, vitrectomy probe, and illuminator and the average of the three was the overall Conjunctival Edema Score at the visit. Only one eye (study eye) contributed to the analysis.	Week 1 post operative
Mean Post-operative Pain Rating at Day 1	The subject was asked to rate post-operative pain in the study eye using a score of 0-10, where 0=no pain and 10=the worst pain imaginable.	Day 1 post operative

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Manager, Surgical, GCRA, Alcon, A Novartis Division

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): August 31, 2016

Study Registration Dates

• First Submitted: June 18, 2015
• First Submitted That Met QC Criteria: June 18, 2015
• First Posted (Estimate): June 23, 2015

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: VRH172-P001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No