RecruitingPhase 4NCT05331664

Dropless Pars Plana Vitrectomy Study


Sponsor

Massachusetts Eye and Ear Infirmary

Enrollment

168 participants

Start Date

Jul 25, 2022

Study Type

INTERVENTIONAL

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

Min Age: 40 Years

Inclusion Criteria1

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

Exclusion Criteria23

  • 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
  • History of ocular incisional surgery within six months of surgery (excluding laser surgery) in surgical eye
  • History of ocular laser surgery within 1 month in surgical eye
  • History of intravitreal injection within 1 month in surgical eye
  • Diagnosis of glaucoma or intraocular pressure more than 21 mmHg in either eye
  • Active or chronic or recurrent uncontrolled ocular or systemic disease
  • Active or history of chronic or recurrent inflammatory eye disease
  • Previous history of steroid response
  • Current treatment with oral, topical, or intravitreal corticosteroids
  • Presence of proliferative vitreoretinopathy at the time of diagnosis
  • Presence of giant retinal tear at the time of diagnosis
  • Diagnosis of proliferative diabetic retinopathy
  • Anterior chamber inflammation on presentation in either eye
  • Signs of ocular infection at presentation in either eye
  • Acute external ocular infections
  • Known or suspected sensitivity or allergy to any of the medications used in the operation or postoperatively
  • Inability to use or apply topical eye drops
  • Requirement for silicone oil as a tamponade agent
  • Individuals with impaired decision-making capacity
  • Non-English-speaking subjects

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Interventions

PROCEDUREPars plana vitrectomy

Standard of care surgery

DRUGTriamcinolone Acetonide 40mg/mL

Sub-tenon injection of triamcinolone acetonide (40mg/mL) at the time of surgery

DRUGMoxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin

Antibiotic eye drop 4 times per day for 1 week after surgery

DRUGPrednisolone 1%

Steroid eye drop 4 times per day tapered by one drop weekly for 4 weeks (4/3/2/1 taper) after surgery

DRUGAtropine 1%

Eye drop daily for 1 week after surgery


Locations(1)

Massachusetts Eye and Ear

Boston, Massachusetts, United States

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NCT05331664