Clinical trial NCT05331664: Dropless Pars Plana Vitrectomy Study
Official title: Dropless Pars Plana Vitrectomy Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Rhegmatogenous Retinal Detachment
Keywords: Vitrectomy
Dropless
Sub-tenon steroids
Postoperative
Inflammation
Randomized clinical trial
Non-inferiority trial
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 168
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Mean anterior chamber cell
timeFrame: Day 7 after surgical procedure
Secondary outcomes:
measure: Mean anterior chamber cell
timeFrame: Day 1, 30 and 90 after surgical procedure
measure: Need for rescue medication (corticosteroid)
timeFrame: Day 1, 7, 30 and 90 after surgical procedure
measure: Intraocular pressure less than 5 or more 30 mmHg
timeFrame: Day 1, 7, 30 and 90 after surgical procedure
measure: Need for medications to reduce intraocular pressure
timeFrame: Day 1, 7, 30 and 90 after surgical procedure
measure: Visual acuity
timeFrame: Day 1, 7, 30 and 90 after surgical procedure
measure: Degree of pain
timeFrame: Day 1, 7, 30 and 90 after surgical procedure
measure: Self-reported adherence to positioning
timeFrame: Day 1 and 7 after surgical procedure
measure: Self-reported adherence to eye drops
timeFrame: Day 1, 7 and 30 after surgical procedure
measure: Progression of cataract
timeFrame: Day 30 and 90 after surgical procedure
measure: Adverse events
timeFrame: Day 1, 7, 30 and 90 after surgical procedure
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts Eye and Ear
state: Massachusetts
Study officials:
affiliation: Massachusetts Eye and Ear
name: Nimesh A. Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paccola L, Jorge R, Barbosa JC, Costa RA, Scott IU. Anti-inflammatory efficacy of a single posterior subtenon injection of triamcinolone acetonide versus prednisolone acetate 1% eyedrops after pars plana vitrectomy. Acta Ophthalmol Scand. 2007 Sep;85(6):603-8. doi: 10.1111/j.1600-0420.2007.00923.x. Epub 2007 Apr 24.
citation: Brown GT, Karth PA, Hunter AA. Novel Postoperative Dropless Protocol for Micro-Incision Vitrectomy Surgery. Ophthalmic Surg Lasers Imaging Retina. 2021 Nov;52(11):587-591. doi: 10.3928/23258160-20211014-01. Epub 2021 Nov 1.
citation: Bonfiglio V, Reibaldi M, Macchi I, Fallico M, Pizzo C, Patane C, Russo A, Longo A, Pizzo A, Cillino G, Cillino S, Vadala M, Rinaldi M, Rejdak R, Nowomiejska K, Toro MD, Avitabile T, Ortisi E. Preoperative, Intraoperative and Postoperative Corticosteroid Use as an Adjunctive Treatment for Rhegmatogenous Retinal Detachment. J Clin Med. 2020 May 21;9(5):1556. doi: 10.3390/jcm9051556.
citation: Assil KK, Greenwood MD, Gibson A, Vantipalli S, Metzinger JL, Goldstein MH. Dropless cataract surgery: modernizing perioperative medical therapy to improve outcomes and patient satisfaction. Curr Opin Ophthalmol. 2021 Jan;32 Suppl 1:S1-S12. doi: 10.1097/ICU.0000000000000708.