Short-Term Outcomes of Different Suture Materials for Sclerotomy Closure

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.

Study Overview

• Status: Unknown
• Conditions: Ophthalmologic Surgical Procedure
• Intervention / Treatment: Procedure: Sclerotomy closure

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient comfort	One month post-operative patient comfort assessed using a 0-10 visual analogue scale	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications		1 month
Scleral/conjunctival inflammation	Rated on a 0 to 4+ scale	1 month
Visual Acuity		1 month
Intraocular Pressure		1 month

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: June 6, 2016
• First Submitted That Met QC Criteria: June 6, 2016
• First Posted (Estimate): June 9, 2016

Study Record Updates

• Last Update Posted (Estimate): June 9, 2016
• Last Update Submitted That Met QC Criteria: June 6, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 20160382

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES