Recruiting

Dropless Vitrectomy

Sponsor:

Massachusetts Eye and Ear Infirmary

Code:

NCT05331664

Conditions

Rhegmatogenous Retinal Detachment

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Accepted

Interventions

Pars plana vitrectomy

Triamcinolone Acetonide 40mg/mL

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

Prednisolone 1%

Atropine 1%

Study Details

Brief 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.

Conditions

Rhegmatogenous Retinal Detachment

Study ID

NCT05331664

Start date

Jul 25, 2022

Status verified date

Jun, 2026

Completion date

Jan 30, 2027

Anticipated

Primary completion date

Jul 25, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Accepted

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
  • 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

Study Design

Enrollment

168 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

Pars plana vitrectomy

Standard of care surgery

Triamcinolone Acetonide 40mg/mL

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

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

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

Prednisolone 1%

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

Atropine 1%

Eye drop daily for 1 week after surgery

Primary outcome measure

  • Mean anterior chamber cell [ Time Frame: Day 7 after surgical procedure ]

Central Contacts and Locations

Central contacts

Nimesh A. Patel, MD

617-523-7900nimesh_patel2@meei.harvard.edu

Sandra Alhoyek, MD

617-523-7900salhoyek@meei.harvard.edu

Locations

Massachusetts Eye and Ear

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Nimesh A Patel, MD

nimesh_patel2@meei.harvard.edu

More Information

Sponsor

Massachusetts Eye and Ear Infirmary

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Keywords

  • Vitrectomy
  • Dropless
  • Sub-tenon steroids
  • Postoperative
  • Inflammation
  • Randomized clinical trial
  • Non-inferiority trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts Eye and Ear Infirmary on 2026-06-26.