AzTrials
AzTrials

Rhegmatogenous Retinal DetachmentPhase 4DVSNCT05331664

Dropless Pars Plana Vitrectomy Study

A Phase 4 study testing Pars plana vitrectomy, Triamcinolone Acetonide 40mg/mL and Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin in people with Rhegmatogenous Retinal Detachment, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for
Rhegmatogenous Retinal Detachment
What is being tested?
Pars plana vitrectomy, Triamcinolone Acetonide 40mg/mL and Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
168 participants
Where
1 siteUnited States
Study dates
25 Jul 2022to 30 Aug 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts Eye and Ear

    Boston, Massachusetts, 02114

Other trials in United States

About this 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.

Read the 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.

Being tested
Pars plana vitrectomy, Triamcinolone Acetonide 40mg/mL, Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin, Prednisolone 1%, Atropine 1%
Keywords
Vitrectomy, Dropless, Sub-tenon steroids, Postoperative, Inflammation, Randomized clinical trial, Non-inferiority trial
Medical subject headings
Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pars plana vitrectomyProcedure or surgery

    Standard of care surgery

  • Triamcinolone Acetonide 40mg/mLDrug

    Also called Kenalog-40

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

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

    Also called Vigamox or Polytrim

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

  • Prednisolone 1%Drug

    Also called Pred forte

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

  • Atropine 1%Drug

    Also called Atropine sulfate

    Eye drop daily for 1 week after surgery

Study groups in NCT05331664
Study groupRoleWhat they receive
Group 1Active 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
Receives: Procedure: Pars plana vitrectomy; Drug: Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin; Drug: Prednisolone 1%; Drug: Atropine 1%
Group 2Active 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
Receives: Procedure: Pars plana vitrectomy; Drug: Triamcinolone Acetonide 40mg/mL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean anterior chamber cell

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

    Measured: Day 7 after surgical procedure

Secondary outcomes (10)

  1. Mean anterior chamber cell

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

    Measured: Day 1, 30 and 90 after surgical procedure

  2. Need for rescue medication (corticosteroid)

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

    Measured: Day 1, 7, 30 and 90 after surgical procedure

  3. Intraocular pressure less than 5 or more 30 mmHg

    Intraocular pressure measured by applanation tonometer or tono-pen

    Measured: Day 1, 7, 30 and 90 after surgical procedure

  4. Need for medications to reduce intraocular pressure

    Need for additional medication to reduce intraocular pressure

    Measured: Day 1, 7, 30 and 90 after surgical procedure

  5. Visual acuity

    Best-corrected visual acuity measured using Snellen chart

    Measured: Day 1, 7, 30 and 90 after surgical procedure

  6. Degree of pain

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

    Measured: Day 1, 7, 30 and 90 after surgical procedure

  7. 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?"

    Measured: Day 1 and 7 after surgical procedure

  8. 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?"

    Measured: Day 1, 7 and 30 after surgical procedure

  9. Progression of cataract

    Evaluation of progression of cataract by Slit Lamp Biomicroscopy

    Measured: Day 30 and 90 after surgical procedure

  10. Adverse events

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

    Measured: Day 1, 7, 30 and 90 after surgical procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2022
  2. Study start25 Jul 2022
  3. Primary completion25 Jul 2026
  4. Study completion30 Aug 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05331664
Sponsor's protocol ID
2022P000046
Acronym
DVS
Status last verified
Sep 2026
First submitted
9 Apr 2022
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 33273209

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pars plana vitrectomy, Triamcinolone Acetonide 40mg/mL and Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin in people with Rhegmatogenous Retinal Detachment, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean anterior chamber cell (time frame: Day 7 after surgical procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05331664, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

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