DVS: Dropless Pars Plana Vitrectomy Study

Sponsor

Massachusetts Eye and Ear Infirmary (Other)

Overall Status

Recruiting

CT.gov ID

NCT05331664

Collaborator

(none)

168

Enrollment

Location

Arms

42.2

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rhegmatogenous Retinal Detachment	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%	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

168 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Dropless Pars Plana Vitrectomy Study

Actual Study Start Date :

Jul 25, 2022

Anticipated Primary Completion Date :

Jul 25, 2025

Anticipated Study Completion Date :

Jan 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Procedure: Pars plana vitrectomy Standard of care surgery Drug: Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin Antibiotic eye drop 4 times per day for 1 week after surgery Other Names: Vigamox or Polytrim Drug: Prednisolone 1% 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 Drug: Atropine 1% Eye drop daily for 1 week after surgery Other Names: Atropine sulfate
Active Comparator: 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	Procedure: Pars plana vitrectomy Standard of care surgery Drug: Triamcinolone Acetonide 40mg/mL Sub-tenon injection of triamcinolone acetonide (40mg/mL) at the time of surgery Other Names: Kenalog-40

Arm

Intervention/Treatment

Active Comparator: 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

Procedure: Pars plana vitrectomy

Standard of care surgery

Drug: Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin

Antibiotic eye drop 4 times per day for 1 week after surgery

Other Names:

Vigamox or Polytrim

Drug: Prednisolone 1%

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

Drug: Atropine 1%

Eye drop daily for 1 week after surgery

Other Names:

Atropine sulfate

Active Comparator: 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

Procedure: Pars plana vitrectomy

Standard of care surgery

Drug: Triamcinolone Acetonide 40mg/mL

Sub-tenon injection of triamcinolone acetonide (40mg/mL) at the time of surgery

Other Names:

Kenalog-40

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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
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)
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts 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
Need for concomitant scleral buckle
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