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OpenTrials
Completed

NCT Number: NCT02477605

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

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.

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Key information

Conditions

Vitreoretinal Disease

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CONSTELLATION® 27-gauge Combined Surgical Pak

Device

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

Device

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 surgery

Procedure

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 23, 2015
Registry last updated
Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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