Massachusetts Eye and Ear
Boston, Massachusetts, 02114, United States
Location status: Recruiting
NCT Number: NCT05331664
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.
Interested in participating?
Request Info40 year and older
All sexes
Interventional
Phase 4
Boston, Massachusetts, 02114, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard of care surgery
Sub-tenon injection of triamcinolone acetonide (40mg/mL) at the time of surgery
Other names: Kenalog-40
Antibiotic eye drop 4 times per day for 1 week after surgery
Other names: Vigamox or Polytrim
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
Eye drop daily for 1 week after surgery
Other names: Atropine sulfate
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
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
Time frame: Day 1, 7, 30 and 90 after surgical procedure
Need for additional medication (corticosteroid) to control post-operative inflammation
Time frame: Day 1, 7, 30 and 90 after surgical procedure
Intraocular pressure measured by applanation tonometer or tono-pen
Time frame: Day 1, 7, 30 and 90 after surgical procedure
Need for additional medication to reduce intraocular pressure
Time frame: Day 1, 7, 30 and 90 after surgical procedure
Best-corrected visual acuity measured using Snellen chart
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)
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?"
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?"
Time frame: Day 30 and 90 after surgical procedure
Evaluation of progression of cataract by Slit Lamp Biomicroscopy
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
Contact information is provided by the study sponsor or research team.
Nimesh A. Patel, MD
CONTACT
Sandra Alhoyek, MD
CONTACT
Massachusetts Eye and Ear Infirmary
Other
Acronym: DVS
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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