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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836210
• Other study ID #: WEH IRB# 15-514
• Status: Completed
• Phase: N/A
• First received: July 14, 2016
• Last updated: November 30, 2016
• Start date: May 2015
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Wills Eye
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Epiretinal Membrane

Intervention

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.

Locations

Country	Name	City	State
United States	Mid Atlantic Retina- Wills Eye Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Wills Eye

Country where clinical trial is conducted

United States, 

References & Publications (8)

Chen E. 25-Gauge transconjunctival sutureless vitrectomy. Curr Opin Ophthalmol. 2007 May;18(3):188-93. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Spirn MJ. Comparison of 25, 23 and 20-gauge vitrectomy. Curr Opin Ophthalmol. 2009 May;20(3):195-9. doi: 10.1097/ICU.0b013e328329eaea. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of sclerotomy site suturing and suture bleb formation		Minimum follow-up 30 days.
Secondary	Rate of post-operative, wound related complications	Rate of complications including hypotony, choroidal detachment, and endophthalmitis	Minimum follow-up of 30 days
Secondary	Change in mean intraocular pressure	Measured in mm Hg by tonometry	Minimum follow-up of 30 days