Dropless Pars Plana Vitrectomy Study

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: t
View:

• Primary rhegmatogenous retinal detachment (mac-on or mac-off) requiring pars plana vitrectomy (23, 25 and 27-gauge)

Locations
United States
Massachusetts
Massachusetts Eye and Ear
RECRUITING
Boston
Contact Information
Primary
Nimesh A. Patel, MD
nimesh_patel2@meei.harvard.edu
617-523-7900
Backup
Sandra Alhoyek, MD
salhoyek@meei.harvard.edu
617-523-7900
Time Frame
Start Date: 2022-07-25
Estimated Completion Date: 2027-01-30
Participants
Target number of participants: 168
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Massachusetts Eye and Ear Infirmary

This content was sourced from clinicaltrials.gov

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