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

Study Overview
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Brief Summary
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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
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Required follow-up for this study is 3 months post treatment.

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

Conditions
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Vitreoretinal Disease

Intervention / Treatment
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* Device: CONSTELLATION® 27-gauge Combined Surgical Pak
* Device: CONSTELLATION® 23-gauge Combined Surgical Pak
* Procedure: Vitrectomy surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |