NCT05331664

Dropless Pars Plana Vitrectomy Study

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Massachusetts Eye and Ear Infirmary · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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.

Detailed 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 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.

Conditions

• Rhegmatogenous Retinal Detachment

Interventions

Type	Name	Description
PROCEDURE	Pars plana vitrectomy	Standard of care surgery
DRUG	Triamcinolone Acetonide 40mg/mL	Sub-tenon injection of triamcinolone acetonide (40mg/mL) at the time of surgery
DRUG	Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin	Antibiotic eye drop 4 times per day for 1 week after surgery
DRUG	Prednisolone 1%	Steroid eye drop 4 times per day tapered by one drop weekly for 4 weeks (4/3/2/1 taper) after surgery
DRUG	Atropine 1%	Eye drop daily for 1 week after surgery

Timeline

• Start date: 2022-07-25
• Primary completion: 2026-07-25
• Completion: 2027-01-30
• First posted: 2022-04-15
• Last updated: 2025-06-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study