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: * 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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
168
Standard of care surgery
Sub-tenon injection of triamcinolone acetonide (40mg/mL) at the time of surgery
Antibiotic eye drop 4 times per day for 1 week after surgery
Massachusetts Eye and Ear
Boston, Massachusetts, United States
RECRUITINGMean anterior chamber cell
Mean anterior chamber cell based on SUN (Standardization of Uveitis Nomenclature) criteria as measured by Slit Lamp Biomicroscopy
Time frame: Day 7 after surgical procedure
Mean anterior chamber cell
Mean anterior chamber cell based on Standardization of Uveitis Nomenclature (SUN) criteria as measured by Slit Lamp Biomicroscopy
Time frame: Day 1, 30 and 90 after surgical procedure
Need for rescue medication (corticosteroid)
Need for additional medication (corticosteroid) to control post-operative inflammation
Time frame: 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
Time frame: Day 1, 7, 30 and 90 after surgical procedure
Need for medications to reduce intraocular pressure
Need for additional medication to reduce intraocular pressure
Time frame: Day 1, 7, 30 and 90 after surgical procedure
Visual acuity
Best-corrected visual acuity measured using Snellen chart
Time frame: 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)
Time frame: Day 1, 7, 30 and 90 after surgical procedure
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Steroid eye drop 4 times per day tapered by one drop weekly for 4 weeks (4/3/2/1 taper) after surgery
Eye drop daily for 1 week after surgery
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?"
Time frame: 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?"
Time frame: Day 1, 7 and 30 after surgical procedure
Progression of cataract
Evaluation of progression of cataract by Slit Lamp Biomicroscopy
Time frame: 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
Time frame: Day 1, 7, 30 and 90 after surgical procedure