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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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
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
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.
- Conditions
- Rhegmatogenous Retinal Detachment
- 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 group | Role | What they receive |
|---|---|---|
| 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 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 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 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.
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)
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
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
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
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
Visual acuity
Best-corrected visual acuity measured using Snellen chart
Measured: 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)
Measured: 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?"
Measured: 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?"
Measured: Day 1, 7 and 30 after surgical procedure
Progression of cataract
Evaluation of progression of cataract by Slit Lamp Biomicroscopy
Measured: 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
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.
- First posted15 Apr 2022
- Study start25 Jul 2022
- Primary completion25 Jul 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rhegmatogenous Retinal DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nimesh Patel, Massachusetts Eye and Ear Infirmary
- Investigators
- Nimesh A. Patel, MD, Principal investigator, Massachusetts Eye and Ear
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 17459031Brown 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 34766851Bonfiglio 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 32455658Assil 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