Dropless Pars Plana Vitrectomy Study

Recruiting now · Phase 4

Conditions studied: Rhegmatogenous Retinal Detachment

In brief

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.

Key facts

Study ID

NCT05331664

Run by

Massachusetts Eye and Ear Infirmary

People needed

168

Starts

2022-07-25

Expected to finish

2027-01-30

Last updated by the study team

2026-06-26

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Primary rhegmatogenous retinal detachment (mac-on or mac-off) requiring pars plana vitrectomy (23, 25 and 27-gauge)

You may not qualify if…

• 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

Where it is running

• Massachusetts Eye and Ear — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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