Dropless Pars Plana Vitrectomy Study — DVS  

Rhegmatogenous Retinal Detachment Clinical Trial

Official title: Dropless Pars Plana Vitrectomy Study

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Retinal Detachment
• Rhegmatogenous Retinal Detachment

• NCT number: NCT05331664
• Study type: Interventional
• Source: Massachusetts Eye and Ear Infirmary
• Contact: Nimesh A. Patel, MD
• Phone: 617-523-7900
• Email: nimesh_patel2@meei.harvard.edu
• Status: Recruiting
• Phase: Phase 4
• Start date: July 25, 2022
• Completion date: January 30, 2026