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Recruiting NCT05331664

Dropless Pars Plana Vitrectomy Study

Phase IV Interventional Rhegmatogenous Retinal Detachment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pars plana vitrectomy, Triamcinolone Acetonide 40mg/mL, Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin, Prednisolone 1%.
Who it may be relevant to
Registry conditions: Rhegmatogenous Retinal Detachment. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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

Primary outcome measures

  • Mean anterior chamber cell [Time frame: Day 7 after surgical procedure]
Secondary outcome measures (10)
  • Mean anterior chamber cell [Time frame: Day 1, 30 and 90 after surgical procedure]
  • Need for rescue medication (corticosteroid) [Time frame: Day 1, 7, 30 and 90 after surgical procedure]
  • Intraocular pressure less than 5 or more 30 mmHg [Time frame: Day 1, 7, 30 and 90 after surgical procedure]
  • Need for medications to reduce intraocular pressure [Time frame: Day 1, 7, 30 and 90 after surgical procedure]
  • Visual acuity [Time frame: Day 1, 7, 30 and 90 after surgical procedure]
  • Degree of pain [Time frame: Day 1, 7, 30 and 90 after surgical procedure]
  • Self-reported adherence to positioning [Time frame: Day 1 and 7 after surgical procedure]
  • Self-reported adherence to eye drops [Time frame: Day 1, 7 and 30 after surgical procedure]
  • Progression of cataract [Time frame: Day 30 and 90 after surgical procedure]
  • Adverse events [Time frame: Day 1, 7, 30 and 90 after surgical procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Massachusetts Eye and Ear — Boston

Publications

  • Paccola L, Jorge R, Barbosa JC, Costa RA, Scott IU. Anti-inflammatory efficacy of a single posterior subtenon injection of triamcinolone acetonide versus prednisolone acetate 1% eyedrops after pars plana vitrectomy. Acta Ophthalmol Scand. 2007 Sep;85(6):603-8. doi: 10.1111/j.1600-0420.2007.00923.x. Epub 2007 Apr 24. PMID 17459031
  • Brown GT, Karth PA, Hunter AA. Novel Postoperative Dropless Protocol for Micro-Incision Vitrectomy Surgery. Ophthalmic Surg Lasers Imaging Retina. 2021 Nov;52(11):587-591. doi: 10.3928/23258160-20211014-01. Epub 2021 Nov 1. PMID 34766851
  • Bonfiglio V, Reibaldi M, Macchi I, Fallico M, Pizzo C, Patane C, Russo A, Longo A, Pizzo A, Cillino G, Cillino S, Vadala M, Rinaldi M, Rejdak R, Nowomiejska K, Toro MD, Avitabile T, Ortisi E. Preoperative, Intraoperative and Postoperative Corticosteroid Use as an Adjunctive Treatment for Rhegmatogenous Retinal Detachment. J Clin Med. 2020 May 21;9(5):1556. doi: 10.3390/jcm9051556. PMID 32455658
  • Assil KK, Greenwood MD, Gibson A, Vantipalli S, Metzinger JL, Goldstein MH. Dropless cataract surgery: modernizing perioperative medical therapy to improve outcomes and patient satisfaction. Curr Opin Ophthalmol. 2021 Jan;32 Suppl 1:S1-S12. doi: 10.1097/ICU.0000000000000708. PMID 33273209

Identifiers

NCT: NCT05331664 · 2022P000046

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗