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

Alcon Research137 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

137

Conditions

Vitreoretinal Disease

Interventions

CONSTELLATION® 27-gauge Combined Surgical PakDEVICE

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 PakDEVICE

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.

Vitrectomy surgeryPROCEDURE

Microincisional pars plana vitrectomy (PPV) surgery for the treatment of various vitreoretinal diseases ranging from simple to advanced cases

Eligibility

Sex: ALLMin age: 22 Years

Medical Language ↔ Plain English

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.

Locations (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: Day 0 preoperative, Day 0 postoperative

Secondary Outcomes

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.

Time frame: 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.

Time frame: Day 1 post operative

Data from ClinicalTrials.gov

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