Dropless Pars Plana Vitrectomy Study
ConditionRhegmatogenous Retinal Detachment
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40+
SponsorMassachusetts Eye and Ear Infirmary
About this trial
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 criteria
Qualifiers
Primary rhegmatogenous retinal detachment (mac-on or mac-off) requiring pars plana vitrectomy (23, 25 and 27-gauge)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Pars plana vitrectomy
- Triamcinolone Acetonide 40mg/mL
- Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin
- Prednisolone 1%
- Atropine 1%
Treatment groups
168 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov