dropless pars plana vitrectomy study

Conditions: Rhegmatogenous Retinal Detachment

Summary: to demonstrate that intraoperative use of subtenon triamcinolone acetonide at the time of surgery without postoperative eye drops is non-inferior to the regimen of postoperative eye drops following primary pars plana vitrectomy for retinal detachment.

this is a non-inferiority, single-center, randomized, controlled, open-label clinical trial. investigators will recruit patients that present to their clinic or emergency department with newly diagnosed mac-on or mac-off rhegmatogenous retinal detachment. patients will be randomized to one of the following groups: * group 1: a total of 84 study subjects (84 eyes) will receive topical antibiotic qid for one week after surgery, topical prednisolone 1% qid tapered by one drop weekly for four weeks (4/3/2/1 taper), and topical atropine 1% daily for one week. * group 2: a total of 84 study subjects (84 eyes) will receive sub-tenon injection of triamcinolone acetonide (40 mg/ml) at the time of surgery, with no post-operative eye drops. both groups will receive subconjunctival injection of antibiotic (cefazolin 50 mg/0.5 ml, moxifloxacin 0.5 mg/0.1 ml, or vancomycin 1 mg/0.1 ml) and subconjunctival injection of dexamethasone (4 mg/ml) at the time of surgery, as well as atropine 1% and antibiotic-steroid ointment (neomycin-polymyxin b-dexamethasone) at the time of surgery.

Eligibility criteria:
inclusion criteria: * primary rhegmatogenous retinal detachment (mac-on or mac-off) requiring pars plana vitrectomy (23, 25 and 27-gauge) exclusion criteria: * need for concomitant lensectomy or cataract surgery * pars plana vitrectomy taking place more than seven days after the initial diagnosis * history of any prior vitreoretinal surgery (excluding laser surgery) in surgical eye * history of previous retinal detachment in surgical eye * history of ocular incisional surgery within six months of surgery (excluding laser surgery) in surgical eye * history of ocular laser surgery within 1 month in surgical eye * history of intravitreal injection within 1 month in surgical eye * diagnosis of glaucoma or intraocular pressure more than 21 mmhg in either eye * active or chronic or recurrent uncontrolled ocular or systemic disease * active or history of chronic or recurrent inflammatory eye disease * previous history of steroid response * current treatment with oral, topical, or intravitreal corticosteroids * presence of proliferative vitreoretinopathy at the time of diagnosis * presence of giant retinal tear at the time of diagnosis * diagnosis of proliferative diabetic retinopathy * anterior chamber inflammation on presentation in either eye * signs of ocular infection at presentation in either eye * acute external ocular infections * known or suspected sensitivity or allergy to any of the medications used in the operation or postoperatively * inability to use or apply topical eye drops * requirement for silicone oil as a tamponade agent * individuals with impaired decision-making capacity * non-english-speaking subjects

Keywords: vitrectomy dropless sub-tenon steroids postoperative inflammation randomized clinical trial non-inferiority trial