Dropless Pars Plana Vitrectomy Study

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts Eye and Ear Infirmary
Study ID
NCT05331664
Phase
PHASE4
Status
Recruiting
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Conditions

  • Rhegmatogenous Retinal Detachment

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 25, 2022
Status verified
Jun 2025
Primary completion
Jul 25, 2026
Completion
Jan 30, 2027

Study Design

Enrollment
168 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Group 1
    * Subconjunctival antibiotic (cefazolin 50 mg/0.5 mL, moxifloxacin 0.5 mg/0.1 mL, or vancomycin 1 mg/0.1 mL) and subconjunctival dexamethasone (4 mg/mL) at the time of surgery * Topical atropine 1% and antibiotic-steroid ointment (neomycin-polymyxin B-dexamethasone) at the time of surgery * Topical moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin; 4 times per day for 1 week after surgery. * Topical prednisolone 1% 1 drop 4 times per day tapered by one drop weekly for 4 weeks (4/3/2/1 taper) * Topical atropine 1% daily for 1 week
  • Active Comparator: Group 2
    * Subtenon triamcinolone acetonide (40 mg/1mLl) at the time of surgery * Subconjunctival antibiotic (cefazolin 50 mg/0.5 mL, moxifloxacin 0.5 mg/0.1 mL, or vancomycin 1 mg/0.1 mL) and subconjunctival dexamethasone (4 mg/mL) at the time of surgery * Topical atropine 1% and antibiotic-steroid ointment (neomycin-polymyxin B-dexamethasone) at the time of surgery * No postoperative eye drops

Primary Outcome Measure

Mean anterior chamber cell [ Time Frame: Day 7 after surgical procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts Eye and EarBostonMassachusetts02114
Nimesh A Patel, MD
[email protected]

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By research site
Massachusetts Eye and Ear· Boston, MA

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