Epiretinal Membrane Clinical Trial
Official title:
27-gauge Vitrectomy Wound Integrity: a Prospective, Randomized Trial Comparing Angled Versus Straight Entry in Fluid-filled Vitrectomized Eyes
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.
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.
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