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Short-Term Outcomes of Different Suture Materials for Sclerotomy Closure

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ClinicalTrials.gov Identifier: NCT02795130
Recruitment Status : Unknown
Verified June 2016 by Ottawa Hospital Research Institute.
Recruitment status was:  Not yet recruiting
First Posted : June 9, 2016
Last Update Posted : June 9, 2016
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Brief Summary:
Small-incision vitrectomy techniques have become increasingly popular, with a number of advantages over the older 20-gauge instrumentation. The beveled wounds created by the 23- and 25-gauge trocar systems theoretically do not require sutured closure. However, a certain fraction of cases, 1% for 25-gauge systems, and 4-38% for 23-gauge systems, do require suture placement. Poor wound closure puts the patient at increased risk of post-operative hypotony and is associated with increased risk of endophthalmitis. Currently, surgeons are divided as to which suture is the best for sclerotomy closure. The current standard of care is 8-0 polyglactin 910 (Vicryl, Ethicon, Cincinnati, OH). This suture is soft and easy to work with; however, it triggers a robust inflammatory response. The alternative is 6-0 plain gut suture, which is more difficult to manipulate and thicker, but causes less tissue inflammation1. The purpose of this study is to prospectively evaluate these two options for sclerotomy closure. The results of this study will enable us to minimize patients' post-operative discomfort while maximizing safety outcomes.

Condition or disease Intervention/treatment Phase
Ophthalmologic Surgical Procedure Procedure: Sclerotomy closure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2016
Estimated Primary Completion Date : June 2017

Arm Intervention/treatment
Experimental: 8-0 polyglactin 910 Procedure: Sclerotomy closure
Comparison between two suture materials: 1) 8-0 polyglactin 910, 2) 6-0 plain gut

Experimental: 6-0 plain gut suture Procedure: Sclerotomy closure
Comparison between two suture materials: 1) 8-0 polyglactin 910, 2) 6-0 plain gut




Primary Outcome Measures :
  1. Patient comfort [ Time Frame: 1 month ]
    One month post-operative patient comfort assessed using a 0-10 visual analogue scale


Secondary Outcome Measures :
  1. Scleral/conjunctival inflammation [ Time Frame: 1 month ]
    Rated on a 0 to 4+ scale

  2. Visual Acuity [ Time Frame: 1 month ]
  3. Intraocular Pressure [ Time Frame: 1 month ]
  4. Complications [ Time Frame: 1 month ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient of Dr. Michael Dollin
  • Age 18 years and older
  • Scheduled to undergo 23-gauge pars plana vitrectomy for any indication that would most likely require sutures (E.g. retinal detachment)

Exclusion Criteria:

  1. History of previous vitrectomy in the study eye
  2. History of scleral buckling in the study eye
  3. Currently on peri-operative corticosteroid medicines (topical or systemic)
  4. Systemic chemotherapy within the preceding 6 months.
  5. History of any disorder or medication use associated with conjunctival, scleral, or episcleral inflammation and/or scarring
  6. History of narcotic abuse

Information from the National Library of Medicine

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): NCT02795130


Contacts
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Contact: Michael Dollin, MD, FRCSC 613-739-6997 mdollin@toh.ca

Sponsors and Collaborators
Ottawa Hospital Research Institute
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT02795130    
Other Study ID Numbers: 20160382
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes