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

• ClinicalTrials.gov Identifier: NCT02477605
• Recruitment Status: Completed
• First Posted: June 23, 2015
• Results First Posted: July 27, 2017
• Last Update Posted: July 2, 2018
• Sponsor: Alcon Research
• Information provided by (Responsible Party): Alcon Research

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Vitreoretinal Disease	Device: CONSTELLATION® 27-gauge Combined Surgical Pak; Device: CONSTELLATION® 23-gauge Combined Surgical Pak; Procedure: Vitrectomy surgery	Not Applicable

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 137 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical Comparison of 27+® and 23-gauge ULTRAVIT® 7500 Cpm Vitrectomy Outcomes
• Actual Study Start Date: July 16, 2015
• Actual Primary Completion Date: June 1, 2016
• Actual Study Completion Date: August 31, 2016

Arms and Interventions

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	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

Outcome Measures

Primary Outcome Measures :

1. Mean Change in Intraocular Pressure (IOP) on Operative Day [ Time Frame: Day 0 preoperative, Day 0 postoperative ]
   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.

Secondary Outcome Measures :

1. Mean Conjunctival Edema Score at Week 1 [ Time Frame: Week 1 post operative ]
   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.
2. Mean Post-operative Pain Rating at Day 1 [ Time Frame: Day 1 post operative ]
   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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Texas

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States, 76134

Sponsors and Collaborators

Alcon Research

Investigators

• Study Director: Clinical Manager, Surgical, GCRA; Alcon, A Novartis Division

More Information

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02477605
• Other Study ID Numbers: VRH172-P001
• First Posted: June 23, 2015
• Results First Posted: July 27, 2017
• Last Update Posted: July 2, 2018
• Last Verified: June 2017

• 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