Short-Term Outcomes of Different Suture Materials for Sclerotomy Closure

• Sponsor: Ottawa Hospital Research Institute (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02795130
• Collaborator: (none)
• Enrollment: 40
• Arms: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ophthalmologic Surgical Procedure	Procedure: Sclerotomy closure	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2016
• Anticipated Primary Completion Date: Jun 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Patient comfort [1 month]

   One month post-operative patient comfort assessed using a 0-10 visual analogue scale

Secondary Outcome Measures

1. Scleral/conjunctival inflammation [1 month]

   Rated on a 0 to 4+ scale

2. Visual Acuity [1 month]

3. Intraocular Pressure [1 month]

4. Complications [1 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Ottawa Hospital Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ottawa Hospital Research Institute
• ClinicalTrials.gov Identifier: NCT02795130
• Other Study ID Numbers: 20160382
• First Posted: Jun 9, 2016
• Last Update Posted: Jun 9, 2016
• Last Verified: Jun 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes

Study Results

No Results Posted as of Jun 9, 2016