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Recruiting
NCT05331664
Dropless Pars Plana Vitrectomy Study
Conditions: Rhegmatogenous Retinal Detachment
Sex: All
Ages: 40 Years – N/A
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 168
Sponsor: Massachusetts Eye and Ear Infirmary
Location: Massachusetts Eye and Ear Boston Massachusetts
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 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
Source: ClinicalTrials.gov (NCT05331664). StuddyBuddy aggregates publicly available trial information.