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27-gauge Vitrectomy Wound Integrity: a Prospective, Randomized Trial Comparing Angled Versus Straight Entry

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ClinicalTrials.gov Identifier: NCT02836210
Recruitment Status : Completed
First Posted : July 18, 2016
Last Update Posted : December 1, 2016
Sponsor:
Information provided by (Responsible Party):
MidAtlantic Retina, Wills Eye

Study Description
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Brief Summary:

To prospectively compare clinical outcomes using straight (perpendicular) versus angled trocar insertion during 27 gauge pars plana vitrectomy surgery for epiretinal membrane

Primary Endpoints:

Sclerotomy suture rates and incidence of suture blebs at the end of 27 gauge MIVS.

Secondary Endpoints:

Rate of postoperative wound-related complications such as hypotony, choroidal detachments, endophthalmitis, and sclerotomy-related retinal tears with a minimum follow-up of 30 days.


Condition or disease Intervention/treatment Phase
Epiretinal Membrane Device: 27-gauge vitrectomy wound construction Not Applicable

Detailed Description:

Microincision vitrectomy surgery (MIVS) has largely replaced use of conventional, 20-gauge vitrectomy, offering more rapid visual recovery, decreased postoperative pain and inflammation, and reduced surgical time with use of smaller diameter instruments1. Most recently, 27 gauge vitrectomy instrumentation has been introduced2, offering an additional small gauge option to the currently available 23, 25, or 25+ gauge systems.

Initial experience with small gauge MIVS yielded mixed results, with early reports noting increased rates of wound-related postoperative complications including hypotony, choroidal detachments, endophthalmitis, and sclerotomy-related retinal tears3,4. However, with more experience and instrument modifications, outcomes with MIVS improved1,3. In a 2010 Ophthalmic Technology Assessment report by the American Academy of Ophthalmology, outcomes of MIVS were found comparable to that of 20 gauge vitrectomy benchmarks5.

Prior studies have established that a two-stage, angled incision results in improved wound integrity with 23, 25, and 25+ MIVS systems6,7, helping to prevent complications such as post-operative endophthalmitis and hypotony. However, in the two clinical series describing outcomes of 27 gauge MIVS, a one-stage, perpendicular wound construction was performed without complication in a series of 31 patients2,8. Thus far, direct comparison between wound construction techniques (one-stage, perpendicular or two-stage, angled) has not been evaluated.

The purpose of this study is to prospectively compare clinical outcomes using straight, one-stage (perpendicular) versus angled, two-stage trocar insertion during 27 gauge minimally invasive vitrectomy surgery (MIVS). The design of the study will be a randomized, clinical trial. Primary outcomes will be sclerotomy suture rates and incidence of suture blebs at the end of 27 gauge MIVS surgery for epiretinal membrane and macular pucker indications (no air or gas tamponade). Secondary endpoints will include rate of postoperative wound-related complications such as hypotony, choroidal detachments, endophthalmitis, and sclerotomy-related retinal tears with a minimum of 30 days follow-up.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Official Title: 27-gauge Vitrectomy Wound Integrity: a Prospective, Randomized Trial Comparing Angled Versus Straight Entry in Fluid-filled Vitrectomized Eyes
Study Start Date : May 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : October 2016

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Angled incision
Patients in this arm will undergo 27-gauge vitrectomy wound construction using angled (tunnel-like) incisions for trocar entry.
 Device: 27-gauge vitrectomy wound construction
Conventional, 3-port pars plana vitrectomy with membrane peeling is performed for epiretinal membrane indication. Angled and straight trocar entry will be directly compared.
Active Comparator: Straight Incision
Patients in this arm undergo 27-gauge vitrectomy wound construction using straight (perpendicular) incisions for trocar entry.
 Device: 27-gauge vitrectomy wound construction
Conventional, 3-port pars plana vitrectomy with membrane peeling is performed for epiretinal membrane indication. Angled and straight trocar entry will be directly compared.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of sclerotomy site suturing and suture bleb formation [ Time Frame: Minimum follow-up 30 days. ]

Secondary Outcome Measures :
  1. Rate of post-operative, wound related complications [ Time Frame: Minimum follow-up of 30 days ]
    Rate of complications including hypotony, choroidal detachment, and endophthalmitis

  2. Change in mean intraocular pressure [ Time Frame: Minimum follow-up of 30 days ]
    Measured in mm Hg by tonometry


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients older than 18 years old undergoing 27 gauge vitrectomy surgery with membrane peel for epiretinal membrane
  • Willing and able to comply with clinic visits and study-related procedures
  • Provide signed informed consent

Exclusion Criteria:

  • History of previous vitrectomy surgery in the study eye.
  • History of previous ocular surgery other than cataract extraction in the study eye.
  • Requirement of an air or gas (SF6, C3F8) bubble at the conclusion of 27 gauge MIVS surgery.
  • Aphakia, ACIOL, unstable PCIOL, and/or lenticular or zonular instability.
  • Glaucoma requiring IOP lowering medications.
  • Pre-existing ocular inflammation/uveitis.
  • Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either require medical or surgical intervention during the 12 week study period to prevent or treat visual loss that might result from that condition. Examples include infectious conjunctivitis, keratitis, and/or scleritis.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836210


Locations
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United States, Pennsylvania
Mid Atlantic Retina- Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Wills Eye
Investigators
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Principal Investigator: Carl D Regillo, MD Wills Eye Hospital
More Information
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Publications:

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Responsible Party: MidAtlantic Retina, Dr. Carl D. Regillo, MD, Wills Eye
ClinicalTrials.gov Identifier: NCT02836210    
Other Study ID Numbers: WEH IRB# 15-514
First Posted: July 18, 2016    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by MidAtlantic Retina, Wills Eye:
27-gauge Pars plana vitrectomy
Additional relevant MeSH terms:
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Epiretinal Membrane
Retinal Diseases
Eye Diseases