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NCT Number: NCT05331664

Dropless Pars Plana Vitrectomy Study

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.

Recruiting

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts Eye and Ear

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Nimesh A Patel, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pars plana vitrectomy

Procedure

Standard of care surgery

Triamcinolone Acetonide 40mg/mL

Drug

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

Other names: Kenalog-40

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

Other names: Vigamox or Polytrim

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

Other names: Pred forte

Atropine 1%

Drug

Eye drop daily for 1 week after surgery

Other names: Atropine sulfate

Primary outcomes

  1. Mean anterior chamber cell

    Time frame: Day 7 after surgical procedure

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

Secondary outcomes

  1. Mean anterior chamber cell

    Time frame: Day 1, 30 and 90 after surgical procedure

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

  2. Need for rescue medication (corticosteroid)

    Time frame: Day 1, 7, 30 and 90 after surgical procedure

    Need for additional medication (corticosteroid) to control post-operative inflammation

  3. Intraocular pressure less than 5 or more 30 mmHg

    Time frame: Day 1, 7, 30 and 90 after surgical procedure

    Intraocular pressure measured by applanation tonometer or tono-pen

  4. Need for medications to reduce intraocular pressure

    Time frame: Day 1, 7, 30 and 90 after surgical procedure

    Need for additional medication to reduce intraocular pressure

  5. Visual acuity

    Time frame: Day 1, 7, 30 and 90 after surgical procedure

    Best-corrected visual acuity measured using Snellen chart

  6. Degree of pain

    Time frame: Day 1, 7, 30 and 90 after surgical procedure

    Degree of pain on a pain scale of 1-10 (0: pain free, 10: unspeakable pain)

  7. Self-reported adherence to positioning

    Time frame: Day 1 and 7 after surgical procedure

    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?"

  8. Self-reported adherence to eye drops

    Time frame: Day 1, 7 and 30 after surgical procedure

    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?"

  9. Progression of cataract

    Time frame: Day 30 and 90 after surgical procedure

    Evaluation of progression of cataract by Slit Lamp Biomicroscopy

  10. Adverse events

    Time frame: Day 1, 7, 30 and 90 after surgical procedure

    Adverse Events including: Endophthalmitis, Re-detachment requiring surgery, Intraocular pressure requiring medication, Need for additional procedures, Any other adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Nimesh A. Patel, MD

CONTACT

[email protected]

617-523-7900

Sandra Alhoyek, MD

CONTACT

[email protected]

617-523-7900

Sponsors and collaborators

Lead sponsor

Massachusetts Eye and Ear Infirmary

Other

Registry information

Acronym: DVS

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Apr 15, 2022
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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