27-gauge Vitrectomy Wound Integrity: a Prospective, Randomized Trial Comparing Angled Versus Straight Entry
NCT ID: NCT02836210
Last Updated: 2016-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
30 participants
INTERVENTIONAL
2015-05-31
2016-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Angled incision
Patients in this arm will undergo 27-gauge vitrectomy wound construction using angled (tunnel-like) incisions for trocar entry.
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.
Straight Incision
Patients in this arm undergo 27-gauge vitrectomy wound construction using straight (perpendicular) incisions for trocar entry.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Willing and able to comply with clinic visits and study-related procedures
* Provide signed informed consent
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Wills Eye
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
MidAtlantic Retina
Dr. Carl D. Regillo, MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Carl D Regillo, MD
Role: PRINCIPAL_INVESTIGATOR
Wills Eye Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mid Atlantic Retina- Wills Eye Institute
Philadelphia, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Thompson JT. Advantages and limitations of small gauge vitrectomy. Surv Ophthalmol. 2011 Mar-Apr;56(2):162-72. doi: 10.1016/j.survophthal.2010.08.003. Epub 2011 Jan 14.
Oshima Y, Wakabayashi T, Sato T, Ohji M, Tano Y. A 27-gauge instrument system for transconjunctival sutureless microincision vitrectomy surgery. Ophthalmology. 2010 Jan;117(1):93-102.e2. doi: 10.1016/j.ophtha.2009.06.043. Epub 2009 Oct 31.
Spirn MJ. Comparison of 25, 23 and 20-gauge vitrectomy. Curr Opin Ophthalmol. 2009 May;20(3):195-9. doi: 10.1097/ICU.0b013e328329eaea.
Chen E. 25-Gauge transconjunctival sutureless vitrectomy. Curr Opin Ophthalmol. 2007 May;18(3):188-93. doi: 10.1097/ICU.0b013e328133889a.
Recchia FM, Scott IU, Brown GC, Brown MM, Ho AC, Ip MS. Small-gauge pars plana vitrectomy: a report by the American Academy of Ophthalmology. Ophthalmology. 2010 Sep;117(9):1851-7. doi: 10.1016/j.ophtha.2010.06.014.
Rizzo S, Barca F, Caporossi T, Mariotti C. Twenty-seven-gauge vitrectomy for various vitreoretinal diseases. Retina. 2015 Jun;35(6):1273-8. doi: 10.1097/IAE.0000000000000545. No abstract available.
Gupta OP, Maguire JI, Eagle RC Jr, Garg SJ, Gonye GE. The competency of pars plana vitrectomy incisions: a comparative histologic and spectrophotometric analysis. Am J Ophthalmol. 2009 Feb;147(2):243-250.e1. doi: 10.1016/j.ajo.2008.08.025. Epub 2008 Oct 23.
Teixeira A, Rezende FA, Salaroli C, Souza N, Sousa BA, Allemann N. In vivo comparison of 23- and 25-gauge sutureless vitrectomy incision architecture using spectral domain optical coherence tomography. J Ophthalmol. 2013;2013:347801. doi: 10.1155/2013/347801. Epub 2013 Mar 4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
WEH IRB# 15-514
Identifier Type: -
Identifier Source: org_study_id