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Dropless Pars Plana Vitrectomy Study

NCT05331664 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2025-06-25

No results posted yet for this study

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

Interventions

PROCEDURE

Pars plana vitrectomy

Standard of care surgery

DRUG

Triamcinolone Acetonide 40mg/mL

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

DRUG

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

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

DRUG

Prednisolone 1%

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

DRUG

Atropine 1%

Eye drop daily for 1 week after surgery

Sponsors & Collaborators

  • Massachusetts Eye and Ear Infirmary

    lead OTHER

Principal Investigators

  • Nimesh A. Patel, MD · Massachusetts Eye and Ear

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-25
Primary Completion
2026-07-25
Completion
2027-01-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05331664 on ClinicalTrials.gov