Short-Term Outcomes of Different Suture Materials for Sclerotomy Closure

Ophthalmologic Surgical Procedure Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02795130
• Other study ID #: 20160382
• Status: Not yet recruiting
• Phase: N/A
• First received: June 6, 2016
• Last updated: June 6, 2016
• Start date: June 2016

Study information

• Verified date: June 2016
• Source: Ottawa Hospital Research Institute
• Contact: Michael Dollin, MD, FRCSC
• Phone: 613-739-6997
• Email: mdollin[@]toh.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ophthalmologic Surgical Procedure

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient comfort	One month post-operative patient comfort assessed using a 0-10 visual analogue scale	1 month	No
Secondary	Scleral/conjunctival inflammation	Rated on a 0 to 4+ scale	1 month	No
Secondary	Visual Acuity		1 month	No
Secondary	Intraocular Pressure		1 month	No
Secondary	Complications		1 month	No