27-gauge Vitrectomy Wound Integrity: a Prospective, Randomized Trial Comparing Angled Versus Straight Entry
Completed · Not applicable
Conditions studied: Epiretinal Membrane
In brief
To prospectively compare clinical outcomes using straight (perpendicular) versus angled trocar insertion during 27 gauge pars plana vitrectomy surgery for epiretinal membrane Primary Endpoints: Sclerotomy suture rates and incidence of suture blebs at the end of 27 gauge MIVS. Secondary Endpoints: Rate of postoperative wound-related complications such as hypotony, choroidal detachments, endophthalmitis, and sclerotomy-related retinal tears with a minimum follow-up of 30 days.
Key facts
- Study ID
- NCT02836210
- Run by
- Wills Eye
- People needed
- 30
- Starts
- 2015-05-01
- Expected to finish
- 2016-10-01
- Last updated by the study team
- 2016-12-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Patients older than 18 years old undergoing 27 gauge vitrectomy surgery with membrane peel for epiretinal membrane
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
You may not qualify if…
- History of previous vitrectomy surgery in the study eye.
- History of previous ocular surgery other than cataract extraction in the study eye.
- Requirement of an air or gas (SF6, C3F8) bubble at the conclusion of 27 gauge MIVS surgery.
- Aphakia, ACIOL, unstable PCIOL, and/or lenticular or zonular instability.
- Glaucoma requiring IOP lowering medications.
- Pre-existing ocular inflammation/uveitis.
- Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either require medical or surgical intervention during the 12 week study period to prevent or treat visual loss that might result from that condition. Examples include infectious conjunctivitis, keratitis, and/or scleritis.
Where it is running
- Mid Atlantic Retina- Wills Eye Institute — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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