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

Not Applicable

Completed

• Conditions: Vitreoretinal Disease
• Interventions: Device: CONSTELLATION® 27-gauge Combined Surgical Pak; Device: CONSTELLATION® 23-gauge Combined Surgical Pak; Procedure: Vitrectomy surgery

• Registration Number: NCT02477605
• Lead Sponsor: Alcon Research

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2015-06-18
• Study First Submitted QC: 2015-06-18
• Study First Posted: 2015-06-23
• Study Start: 2015-07-16
• Primary Completion: 2016-06-01
• Study Completion: 2016-08-31
• Results First Submitted: 2017-05-30
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-28
• Results First Posted: 2017-07-27
• Last Update Submitted: 2018-05-31
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
27-gauge pak	CONSTELLATION® 27-gauge Combined Surgical Pak	CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery
23-gauge pak	Vitrectomy surgery	CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery
27-gauge pak	Vitrectomy surgery	CONSTELLATION® 27-gauge combined surgical pak used during vitrectomy surgery
23-gauge pak	CONSTELLATION® 23-gauge Combined Surgical Pak	CONSTELLATION® 23-gauge combined surgical pak used during vitrectomy surgery

Primary Outcome Measures

Name	Time	Method
Mean Change in Intraocular Pressure (IOP) on Operative Day	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

Name	Time	Method
Mean Post-operative Pain Rating at Day 1	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.
Mean Conjunctival Edema Score at Week 1	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.

Trial Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States