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

Vitreoretinal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02477605
• Other study ID #: VRH172-P001
• Status: Completed
• Phase: N/A
• Start date: July 16, 2015
• Est. completion date: August 31, 2016

Study information

• Verified date: June 2017
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: August 31, 2016
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Vitreoretinal Disease

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   Results from the Novartis Clinical Trial Results Website