Status:
RECRUITING
Dropless Pars Plana Vitrectomy Study
Lead Sponsor:
Massachusetts Eye and Ear Infirmary
Conditions:
Rhegmatogenous Retinal Detachment
Eligibility:
All Genders
40+ years
Phase:
PHASE4
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 pr...
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 diagnos...
Eligibility Criteria
Inclusion
- Primary rhegmatogenous retinal detachment (mac-on or mac-off) requiring pars plana vitrectomy (23, 25 and 27-gauge)
Exclusion
- 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
Key Trial Info
Start Date :
July 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2027
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT05331664
Start Date
July 25 2022
End Date
January 30 2027
Last Update
June 25 2025
Active Locations (1)
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1
Massachusetts Eye and Ear
Boston, Massachusetts, United States, 02114