Dropless Pars Plana Vitrectomy Study (DVS)

  • STATUS
    Recruiting
  • End date
    Jan 30, 2026
  • participants needed
    168
  • sponsor
    Massachusetts Eye and Ear Infirmary
Updated on 4 October 2022
Accepts healthy volunteers

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.

Description

This is a non-inferiority, single-center, randomized, controlled, open-label clinical trial. Investigators will recruit patients that present to their clinic or emergency department with newly diagnosed mac-on or mac-off rhegmatogenous retinal detachment. Patients will be randomized to one of the following groups:

  • Group 1: A total of 84 study subjects (84 eyes) will receive topical antibiotic qid for one week after surgery, topical prednisolone 1% qid tapered by one drop weekly for four weeks (4/3/2/1 taper), and topical atropine 1% daily for one week.
  • Group 2: A total of 84 study subjects (84 eyes) will receive sub-tenon injection of triamcinolone acetonide (40 mg/mL) at the time of surgery, with no post-operative eye drops.

Both groups will receive subconjunctival injection of antibiotic (cefazolin 50 mg/0.5 ml, moxifloxacin 0.5 mg/0.1 ml, or vancomycin 1 mg/0.1 ml) and subconjunctival injection of dexamethasone (4 mg/ml) at the time of surgery, as well as atropine 1% and antibiotic-steroid ointment (neomycin-polymyxin B-dexamethasone) at the time of surgery.

Details
Condition Rhegmatogenous Retinal Detachment
Treatment Pars Plana Vitrectomy, Triamcinolone Acetonide 40mg/mL, Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin, Prednisolone 1%, Atropine 1%
Clinical Study IdentifierNCT05331664
SponsorMassachusetts Eye and Ear Infirmary
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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