Dropless Pars Plana Vitrectomy Study (DVS)
Rhegmatogenous Retinal Detachment
About this trial
This is an interventional treatment trial for Rhegmatogenous Retinal Detachment focused on measuring Vitrectomy, Dropless, Sub-tenon steroids, Postoperative, Inflammation, Randomized clinical trial, Non-inferiority trial
Eligibility Criteria
Inclusion Criteria:
- Primary rhegmatogenous retinal detachment (mac-on or mac-off) requiring pars plana vitrectomy (23, 25 and 27-gauge)
Exclusion Criteria:
- Need for concomitant lensectomy or cataract surgery
- Need for concomitant scleral buckle
- 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
Sites / Locations
- Massachusetts Eye and EarRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Group 1
Group 2
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
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