Short-Term Outcomes of Different Suture Materials for Sclerotomy Closure
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02795130 |
Recruitment Status : Unknown
Verified June 2016 by Ottawa Hospital Research Institute.
Recruitment status was: Not yet recruiting
First Posted : June 9, 2016
Last Update Posted : June 9, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ophthalmologic Surgical Procedure | Procedure: Sclerotomy closure | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | June 2016 |
Estimated Primary Completion Date : | June 2017 |
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 |
- Patient comfort [ Time Frame: 1 month ]One month post-operative patient comfort assessed using a 0-10 visual analogue scale
- Scleral/conjunctival inflammation [ Time Frame: 1 month ]Rated on a 0 to 4+ scale
- Visual Acuity [ Time Frame: 1 month ]
- Intraocular Pressure [ Time Frame: 1 month ]
- Complications [ Time Frame: 1 month ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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:
- History of previous vitrectomy in the study eye
- History of scleral buckling in the study eye
- Currently on peri-operative corticosteroid medicines (topical or systemic)
- Systemic chemotherapy within the preceding 6 months.
- History of any disorder or medication use associated with conjunctival, scleral, or episcleral inflammation and/or scarring
- History of narcotic abuse

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795130
Contact: Michael Dollin, MD, FRCSC | 613-739-6997 | mdollin@toh.ca |
Responsible Party: | Ottawa Hospital Research Institute |
ClinicalTrials.gov Identifier: | NCT02795130 |
Other Study ID Numbers: |
20160382 |
First Posted: | June 9, 2016 Key Record Dates |
Last Update Posted: | June 9, 2016 |
Last Verified: | June 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |