Dropless Pars Plana Vitrectomy Study (DVS)

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.

Study Overview

• Status: Recruiting
• Conditions: Rhegmatogenous Retinal Detachment
• Intervention / Treatment: Procedure: Pars plana vitrectomy; Drug: Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin; Drug: Prednisolone 1%; Drug: Atropine 1%; Drug: Triamcinolone Acetonide 40mg/mL

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.

• Study Type: Interventional
• Enrollment (Estimated): 168
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Nimesh A. Patel, MD; Phone Number: 617-523-7900; Email: nimesh_patel2@meei.harvard.edu
• Study Contact Backup: Name: Sandra Alhoyek, MD; Phone Number: 617-523-7900; Email: salhoyek@meei.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts Eye and Ear
      • Contact: Nimesh A Patel, MD; Email: nimesh_patel2@meei.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1; 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; Standard of care 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; Other Names: Vigamox or Polytrim; 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; Other Names: Pred forte; Drug: Atropine 1%; Eye drop daily for 1 week after surgery; Other Names: Atropine sulfate
Active Comparator: Group 2; 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; Standard of care surgery; Drug: Triamcinolone Acetonide 40mg/mL; Sub-tenon injection of triamcinolone acetonide (40mg/mL) at the time of surgery; Other Names: Kenalog-40

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean anterior chamber cell	Mean anterior chamber cell based on Standardization of Uveitis Nomenclature (SUN) criteria as measured by Slit Lamp Biomicroscopy	Day 1, 30 and 90 after surgical procedure
Need for rescue medication (corticosteroid)	Need for additional medication (corticosteroid) to control post-operative inflammation	Day 1, 7, 30 and 90 after surgical procedure
Intraocular pressure less than 5 or more 30 mmHg	Intraocular pressure measured by applanation tonometer or tono-pen	Day 1, 7, 30 and 90 after surgical procedure
Need for medications to reduce intraocular pressure	Need for additional medication to reduce intraocular pressure	Day 1, 7, 30 and 90 after surgical procedure
Visual acuity	Best-corrected visual acuity measured using Snellen chart	Day 1, 7, 30 and 90 after surgical procedure
Degree of pain	Degree of pain on a pain scale of 1-10 (0: pain free, 10: unspeakable pain)	Day 1, 7, 30 and 90 after surgical procedure
Self-reported adherence to positioning	Assessment of self-reported adherence to positioning: "Over the past day or week, what percentage of time or number of hours per day do you think you adhered with the recommended positioning?"	Day 1 and 7 after surgical procedure
Self-reported adherence to eye drops	Assessment of self-reported adherence to eye drops in the control group: "Over the past week or month, what percentage of your drops do you think you took correctly?"	Day 1, 7 and 30 after surgical procedure
Progression of cataract	Evaluation of progression of cataract by Slit Lamp Biomicroscopy	Day 30 and 90 after surgical procedure
Adverse events	Adverse Events including: Endophthalmitis, Re-detachment requiring surgery, Intraocular pressure requiring medication, Need for additional procedures, Any other adverse events	Day 1, 7, 30 and 90 after surgical procedure

Collaborators and Investigators

• Sponsor: Massachusetts Eye and Ear Infirmary
• Investigators: Principal Investigator: Nimesh A. Patel, MD, Massachusetts Eye and Ear

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2022
• Primary Completion (Estimated): July 25, 2026
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: April 9, 2022
• First Submitted That Met QC Criteria: April 9, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 20, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Inflammation; Randomized clinical trial; Vitrectomy; Postoperative; Non-inferiority trial; Dropless; Sub-tenon steroids
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Detachment; Contraceptive Agents, Hormonal; Anti-Bacterial Agents; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Autonomic Agents; Peripheral Nervous System Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Enzyme Inhibitors; Reproductive Control Agents; Folic Acid Antagonists; Neurotransmitter Agents; Anti-Arrhythmia Agents; Adjuvants, Anesthesia; Cytochrome P-450 Enzyme Inhibitors; Topoisomerase Inhibitors; Topoisomerase II Inhibitors; Antimalarials; Antiprotozoal Agents; Antiparasitic Agents; Respiratory System Agents; Anti-Asthmatic Agents; Anti-Dyskinesia Agents; Bronchodilator Agents; Contraceptive Agents, Female; Contraceptive Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Parasympatholytics; Mydriatics; Contraceptives, Oral, Combined; Contraceptives, Oral; Anti-Infective Agents, Urinary; Cytochrome P-450 CYP2C8 Inhibitors; Moxifloxacin; Prednisolone; Prednisolone acetate; Atropine; Triamcinolone; Norgestimate, ethinyl estradiol drug combination; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate; Trimethoprim; Polymyxins
• Other Study ID Numbers: 2022P000046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes