NCT05331664PHASE4RecruitingAccepts Healthy Volunteers

Dropless Pars Plana Vitrectomy Study

Massachusetts Eye and Ear Infirmary

Start Date

7/25/2022

Completion Date

1/30/2027

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.

Detailed 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.

Eligibility Criteria

Age Range: 40 years to No maximum

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

Interventions

PROCEDURE

Pars plana vitrectomy

DRUG

Triamcinolone Acetonide 40mg/mL

DRUG

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

DRUG

Prednisolone 1%

DRUG

Atropine 1%

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Conditions

Rhegmatogenous Retinal Detachment

Locations

Massachusetts Eye and Ear

Boston, Massachusetts 02114

United States