Ophthalmologic Surgical Procedure
Conditions
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.
Interventions
PROCEDURESclerotomy closure
Comparison between two suture materials: 1) 8-0 polyglactin 910, 2) 6-0 plain gut
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient comfort | 1 month | One month post-operative patient comfort assessed using a 0-10 visual analogue scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Scleral/conjunctival inflammation | 1 month | Rated on a 0 to 4+ scale |
| Visual Acuity | 1 month | — |
| Intraocular Pressure | 1 month | — |
| Complications | 1 month | — |
Contacts
Primary ContactMichael Dollin, MD, FRCSC
Outcome results
None listed