27-gauge Vitrectomy Wound Integrity: a Prospective, Randomized Trial Comparing Angled Versus Straight Entry
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
July 14, 2016
CompletedFirst Posted
Study publicly available on registry
July 18, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedDecember 1, 2016
November 1, 2016
1.2 years
July 14, 2016
November 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of sclerotomy site suturing and suture bleb formation
Minimum follow-up 30 days.
Secondary Outcomes (2)
Rate of post-operative, wound related complications
Minimum follow-up of 30 days
Change in mean intraocular pressure
Minimum follow-up of 30 days
Study Arms (2)
Angled incision
ACTIVE COMPARATORPatients in this arm will undergo 27-gauge vitrectomy wound construction using angled (tunnel-like) incisions for trocar entry.
Straight Incision
ACTIVE COMPARATORPatients in this arm undergo 27-gauge vitrectomy wound construction using straight (perpendicular) incisions for trocar entry.
Interventions
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
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wills Eyelead
Study Sites (1)
Mid Atlantic Retina- Wills Eye Institute
Philadelphia, Pennsylvania, 19107, United States
Related Publications (8)
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.
PMID: 21236459BACKGROUNDOshima 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.
PMID: 19880185BACKGROUNDSpirn MJ. Comparison of 25, 23 and 20-gauge vitrectomy. Curr Opin Ophthalmol. 2009 May;20(3):195-9. doi: 10.1097/ICU.0b013e328329eaea.
PMID: 19390437BACKGROUNDChen E. 25-Gauge transconjunctival sutureless vitrectomy. Curr Opin Ophthalmol. 2007 May;18(3):188-93. doi: 10.1097/ICU.0b013e328133889a.
PMID: 17435424BACKGROUNDRecchia 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.
PMID: 20816248BACKGROUNDRizzo 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.
PMID: 25946694BACKGROUNDGupta 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.
PMID: 18947818BACKGROUNDTeixeira 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.
PMID: 23533705BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carl D Regillo, MD
Wills Eye Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Carl D. Regillo, MD
Study Record Dates
First Submitted
July 14, 2016
First Posted
July 18, 2016
Study Start
May 1, 2015
Primary Completion
July 1, 2016
Study Completion
October 1, 2016
Last Updated
December 1, 2016
Record last verified: 2016-11