Dropless Pars Plana Vitrectomy Study
Massachusetts Eye and Ear Infirmary
168 participants
Jul 25, 2022
INTERVENTIONAL
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.
Eligibility
Inclusion Criteria1
- Primary rhegmatogenous retinal detachment (mac-on or mac-off) requiring pars plana vitrectomy (23, 25 and 27-gauge)
Exclusion Criteria23
- 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
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Interventions
Standard of care surgery
Sub-tenon injection of triamcinolone acetonide (40mg/mL) at the time of surgery
Antibiotic eye drop 4 times per day for 1 week after surgery
Steroid eye drop 4 times per day tapered by one drop weekly for 4 weeks (4/3/2/1 taper) after surgery
Eye drop daily for 1 week after surgery
Locations(1)
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NCT05331664