Dropless Pars Plana Vitrectomy Study

NCT05331664 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 2022P000046
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Vitrectomy; Dropless; Sub-tenon steroids; Postoperative; Inflammation; Randomized clinical trial; Non-inferiority trial

Outcome Measures

Primary Outcomes (1)

• Mean anterior chamber cell

  Mean anterior chamber cell based on SUN (Standardization of Uveitis Nomenclature) criteria as measured by Slit Lamp Biomicroscopy

  Day 7 after surgical procedure

Secondary Outcomes (10)

• Mean anterior chamber cell

  Day 1, 30 and 90 after surgical procedure

• Need for rescue medication (corticosteroid)

  Day 1, 7, 30 and 90 after surgical procedure

• Intraocular pressure less than 5 or more 30 mmHg

  Day 1, 7, 30 and 90 after surgical procedure

• Need for medications to reduce intraocular pressure

  Day 1, 7, 30 and 90 after surgical procedure

• Visual acuity

  Day 1, 7, 30 and 90 after surgical procedure

Study Arms (2)

Group 1

ACTIVE COMPARATOR

* 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

Procedure: Pars plana vitrectomy; Drug: Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin; Drug: Prednisolone 1%; Drug: Atropine 1%

Group 2

ACTIVE COMPARATOR

* 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

Procedure: Pars plana vitrectomy; Drug: Triamcinolone Acetonide 40mg/mL

Interventions

Pars plana vitrectomy PROCEDURE

Standard of care surgery

Group 1; Group 2

Triamcinolone Acetonide 40mg/mL DRUG

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

Also known as: Kenalog-40

Group 2

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

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

Also known as: Vigamox or Polytrim

Group 1

Prednisolone 1% DRUG

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

Also known as: Pred forte

Group 1

Atropine 1% DRUG

Eye drop daily for 1 week after surgery

Also known as: Atropine sulfate

Group 1

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary rhegmatogenous retinal detachment (mac-on or mac-off) requiring pars plana vitrectomy (23, 25 and 27-gauge)

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Study Sites (1)

Massachusetts Eye and Ear

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• A retrospective consecutive case series showing that single subconjunctival triamcinolone acetonide injection at the end of surgery may represent a reasonable alternative to requiring patients to use a steroid drop taper following vitreoretinal surgery.

MeSH Terms

Conditions

Inflammation

Interventions

Triamcinolone Acetonide; Triamcinolone; Moxifloxacin; Polymyxins; 1(beta)-D-arabinofuranosylcytosine-5'-diphosphate prednisolone; prednisolone acetate; Atropine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Peptides, Cyclic; Macrocyclic Compounds; Lipopeptides; Lipids; Antimicrobial Cationic Peptides; Peptides; Amino Acids, Peptides, and Proteins; Antimicrobial Peptides; Pore Forming Cytotoxic Proteins; Membrane Proteins; Proteins; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Study Officials

• Nimesh A. Patel, MD

  Massachusetts Eye and Ear

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nimesh A. Patel, MD

CONTACT

617-523-7900; nimesh_patel2@meei.harvard.edu

Sandra Alhoyek, MD

CONTACT

617-523-7900; salhoyek@meei.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 9, 2022
• First Posted: April 15, 2022
• Study Start: July 25, 2022
• Primary Completion (Estimated): July 25, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)