Dropless Pars Plana Vitrectomy Study
Overview
- Phase
- Phase 4
- Intervention
- Atropine 1%
- Conditions
- Rhegmatogenous Retinal Detachment
- Sponsor
- Massachusetts Eye and Ear Infirmary
- Enrollment
- 168
- Locations
- 1
- Primary Endpoint
- Mean anterior chamber cell
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief 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.
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.
Investigators
Nimesh Patel
Principal Investigator
Massachusetts Eye and Ear Infirmary
Eligibility Criteria
Inclusion Criteria
- •Primary rhegmatogenous retinal detachment (mac-on or mac-off) requiring pars plana vitrectomy (23, 25 and 27-gauge)
Exclusion Criteria
- •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
- •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
Arms & Interventions
Group 1
* 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
Intervention: Atropine 1%
Group 1
* 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
Intervention: Pars plana vitrectomy
Group 1
* 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
Intervention: Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin
Group 1
* 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
Intervention: Prednisolone 1%
Group 2
* 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
Intervention: Pars plana vitrectomy
Group 2
* 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
Intervention: Triamcinolone Acetonide 40mg/mL
Outcomes
Primary Outcomes
Mean anterior chamber cell
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
Secondary Outcomes
- Mean anterior chamber cell(Day 1, 30 and 90 after surgical procedure)
- Need for rescue medication (corticosteroid)(Day 1, 7, 30 and 90 after surgical procedure)
- Intraocular pressure less than 5 or more 30 mmHg(Day 1, 7, 30 and 90 after surgical procedure)
- Need for medications to reduce intraocular pressure(Day 1, 7, 30 and 90 after surgical procedure)
- Visual acuity(Day 1, 7, 30 and 90 after surgical procedure)
- Degree of pain(Day 1, 7, 30 and 90 after surgical procedure)
- Self-reported adherence to positioning(Day 1 and 7 after surgical procedure)
- Self-reported adherence to eye drops(Day 1, 7 and 30 after surgical procedure)
- Progression of cataract(Day 30 and 90 after surgical procedure)
- Adverse events(Day 1, 7, 30 and 90 after surgical procedure)