Short-Term Outcomes of Different Suture Materials for Sclerotomy Closure

Not Applicable

• Conditions: Ophthalmologic Surgical Procedure
• Interventions: Procedure: Sclerotomy closure

• Registration Number: NCT02795130
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-06
• Study Start: 2016-06
• Study First Submitted: 2016-06-06
• Study First Submitted QC: 2016-06-06
• Last Update Submitted: 2016-06-06
• Study First Posted: 2016-06-09
• Last Update Posted: 2016-06-09
• Primary Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
8-0 polyglactin 910	Sclerotomy closure	-
6-0 plain gut suture	Sclerotomy closure	-

Primary Outcome Measures

Name	Time	Method
Patient comfort	1 month	One month post-operative patient comfort assessed using a 0-10 visual analogue scale

Secondary Outcome Measures

Name	Time	Method
Complications	1 month
Visual Acuity	1 month
Scleral/conjunctival inflammation	1 month	Rated on a 0 to 4+ scale
Intraocular Pressure	1 month