Dropless Pars Plana Vitrectomy Study
Massachusetts Eye and Ear Infirmary
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.
Description
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 subject…
Eligibility
- Age range
- 40+ years
- Sex
- All
- Healthy volunteers
- Yes
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 mo…
Interventions
- ProcedurePars plana vitrectomy
Standard of care surgery
- DrugTriamcinolone Acetonide 40mg/mL
Sub-tenon injection of triamcinolone acetonide (40mg/mL) at the time of surgery
- DrugMoxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin
Antibiotic eye drop 4 times per day for 1 week after surgery
- DrugPrednisolone 1%
Steroid eye drop 4 times per day tapered by one drop weekly for 4 weeks (4/3/2/1 taper) after surgery
- DrugAtropine 1%
Eye drop daily for 1 week after surgery
Location
- Massachusetts Eye and EarBoston, Massachusetts