Dropless Pars Plana Vitrectomy Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Dropless Pars Plana Vitrectomy Study

Conditions
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Rhegmatogenous Retinal Detachment

Intervention / Treatment
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* Procedure: Pars plana vitrectomy
* Drug: Triamcinolone Acetonide 40mg/mL
* Drug: Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin
* Drug: Prednisolone 1%
* Drug: Atropine 1%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>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 | Procedure: Pars plana vitrectomy<br>* Standard of care surgery<br>Drug: Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin<br>* Antibiotic eye drop 4 times per day for 1 week after surgery<br>* Other names: Vigamox or Polytrim;Drug: Prednisolone 1%<br>* Steroid eye drop 4 times per day tapered by one drop weekly for 4 weeks (4/3/2/1 taper) after surgery<br>* Other names: Pred forte;Drug: Atropine 1%<br>* Eye drop daily for 1 week after surgery<br>* Other names: Atropine sulfate;|
| Active Comparator: Group 2<br>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 | Procedure: Pars plana vitrectomy<br>* Standard of care surgery<br>Drug: Triamcinolone Acetonide 40mg/mL<br>* Sub-tenon injection of triamcinolone acetonide (40mg/mL) at the time of surgery<br>* Other names: Kenalog-40;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitrectomy, Dropless, Sub-tenon steroids, Postoperative, Inflammation, Randomized clinical trial, Non-inferiority trial