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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.
Age
40 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Massachusetts Eye and Ear
Boston, Massachusetts, United States
Start Date
July 25, 2022
Primary Completion Date
July 25, 2026
Completion Date
January 30, 2027
Last Updated
June 25, 2025
168
ESTIMATED participants
Pars plana vitrectomy
PROCEDURE
Triamcinolone Acetonide 40mg/mL
DRUG
Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin
DRUG
Prednisolone 1%
DRUG
Atropine 1%
DRUG
Lead Sponsor
Massachusetts Eye and Ear Infirmary
NCT06541574
NCT07054281
Data Source & Attribution
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