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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Active Comparator |
|
|
| Group 2 | Active Comparator |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pars plana vitrectomy | Procedure | Standard of care surgery |
| |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nimesh A. Patel, MD | Contact | 617-523-7900 | nimesh_patel2@meei.harvard.edu | |
| Sandra Alhoyek, MD | Contact | 617-523-7900 | salhoyek@meei.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nimesh A. Patel, MD | Massachusetts Eye and Ear | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts Eye and Ear | Recruiting | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17459031 | Background | 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. | |
| 34766851 |
| Label | URL |
|---|---|
| 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. | View source |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014222 | Triamcinolone Acetonide |
| D014221 | Triamcinolone |
| D000077266 | Moxifloxacin |
| D011113 | Polymyxins |
| C025494 | 1(beta)-D-arabinofuranosylcytosine-5'-diphosphate prednisolone |
| C009935 | prednisolone acetate |
| D001285 | Atropine |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Triamcinolone Acetonide 40mg/mL |
| Drug |
Sub-tenon injection of triamcinolone acetonide (40mg/mL) at the time of surgery |
|
|
| 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 |
|
|
| 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 |
|
|
| Atropine 1% | Drug | Eye drop daily for 1 week after surgery |
|
|
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 |
| 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. |
| 32455658 | 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. |
| 33273209 | 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. |
| D011083 |
| Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D023181 | Antimicrobial Cationic Peptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000089882 | Antimicrobial Peptides |
| D052899 | Pore Forming Cytotoxic Proteins |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |