Dropless Pars Plana Vitrectomy Study (DVS)

Mass Eye and Ear

Status and phase: Enrolling; Phase 4

Conditions: Rhegmatogenous Retinal Detachment

Treatments: Procedure: Pars plana vitrectomy; Drug: Atropine 1%; Drug: Triamcinolone Acetonide 40mg/mL; Drug: Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin; Drug: Prednisolone 1%

Study type: Interventional

Funder types: Other

Identifiers

NCT05331664

2022P000046

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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168 participants in 2 patient groups

Group 1

Active Comparator group

Description:

* 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

Treatment:

Drug: Prednisolone 1%

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

Drug: Atropine 1%

Procedure: Pars plana vitrectomy

Group 2

Active Comparator group

Description:

* 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

Treatment:

Drug: Triamcinolone Acetonide 40mg/mL

Procedure: Pars plana vitrectomy