Short-Term Outcomes of Different Suture Materials for Sclerotomy Closure

Ottawa Hospital Research Institute

Status: Unknown

Conditions: Ophthalmologic Surgical Procedure

Treatments: Procedure: Sclerotomy closure

Study type: Interventional

Funder types: Other

Identifiers

NCT02795130

20160382

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

8-0 polyglactin 910

Experimental group

Treatment:

Procedure: Sclerotomy closure

6-0 plain gut suture

Experimental group

Treatment:

Procedure: Sclerotomy closure