Rhegmatogenous Retinal Detachment
Conditions
Keywords
Vitrectomy, Dropless, Sub-tenon steroids, Postoperative, Inflammation, Randomized clinical trial, Non-inferiority trial
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.
Interventions
PROCEDUREPars plana vitrectomy
Standard of care surgery
Sub-tenon injection of triamcinolone acetonide (40mg/mL) at the time of surgery
DRUGMoxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin
Antibiotic eye drop 4 times per day for 1 week after surgery
DRUGPrednisolone 1%
Steroid eye drop 4 times per day tapered by one drop weekly for 4 weeks (4/3/2/1 taper) after surgery
DRUGAtropine 1%
Eye drop daily for 1 week after surgery
Sponsors
Massachusetts Eye and Ear Infirmary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean anterior chamber cell | Day 7 after surgical procedure | Mean anterior chamber cell based on SUN (Standardization of Uveitis Nomenclature) criteria as measured by Slit Lamp Biomicroscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Need for rescue medication (corticosteroid) | Day 1, 7, 30 and 90 after surgical procedure | Need for additional medication (corticosteroid) to control post-operative inflammation |
| Intraocular pressure less than 5 or more 30 mmHg | Day 1, 7, 30 and 90 after surgical procedure | Intraocular pressure measured by applanation tonometer or tono-pen |
| Need for medications to reduce intraocular pressure | Day 1, 7, 30 and 90 after surgical procedure | Need for additional medication to reduce intraocular pressure |
| Visual acuity | Day 1, 7, 30 and 90 after surgical procedure | Best-corrected visual acuity measured using Snellen chart |
| Mean anterior chamber cell | 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 |
| Self-reported adherence to positioning | 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? |
| Self-reported adherence to eye drops | 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? |
| Progression of cataract | Day 30 and 90 after surgical procedure | Evaluation of progression of cataract by Slit Lamp Biomicroscopy |
| Adverse events | 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 |
| Degree of pain | 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) |
Countries
United States
Contacts
Primary ContactNimesh A. Patel, MD
Backup ContactSandra Alhoyek, MD
Outcome results
None listed