Actively Recruiting
Led by Massachusetts Eye and Ear Infirmary · Updated on 2025-06-25
168
Participants Needed
1
Research Sites
27 weeks
Total Duration
Researchers are examining whether using subtenon triamcinolone acetonide during surgery without the need for postoperative eye drops is as effective as the standard regimen of postoperative eye drops in patients undergoing primary pars plana vitrectomy for rhegmatogenous retinal detachment. This study is a non-inferiority, randomized, controlled trial conducted at a single center, focusing on patients newly diagnosed with mac-on or mac-off rhegmatogenous retinal detachment. Participants will be assigned to one of two treatment groups. One group will receive topical antibiotics four times daily for one week, prednisolone eye drops tapered over four weeks, and atropine eye drops daily for one week after surgery. The second group will receive a subtenon injection of triamcinolone acetonide at the time of surgery without any postoperative eye drops. Both groups will also receive subconjunctival antibiotics and dexamethasone injections during surgery, as well as atropine and antibiotic-steroid ointment at the time of surgery. During the study, participants will be monitored at multiple time points including days 1, 7, 30, and 90 after surgery. Assessments will include measurements of anterior chamber cell inflammation, intraocular pressure, visual acuity, pain levels, and adherence to positioning and eye drop use. The need for additional medications, progression of cataracts, and any adverse events will also be tracked. This careful follow-up aims to evaluate the safety and effectiveness of the treatments over three months.
CONDITIONS
Dropless Pars Plana Vitrectomy Study
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - 1 day
Participants undergo pars plana vitrectomy surgery with associated injections and ointments given at the time of surgery.
1 surgery visit (in-person)
Duration - Up to 4 weeks after surgery
Participants receive post-operative medication according to their group assignment: Group 1 uses topical antibiotics, steroids, and atropine eye drops for up to 4 weeks; Group 2 receives no post-operative eye drops.
Follow-up visits on Day 1, 7, 30, and 90 after surgery
Duration - Up to 3 months after surgery
Participants are monitored for safety, visual acuity, intraocular pressure, cataract progression, and adherence to treatment during follow-up visits.
Follow-up visits on Day 1, 7, 30, and 90 after surgery
Total: 1 location
1
Massachusetts Eye and Ear
Boston, Massachusetts, United States, 02114
Actively Recruiting
N
Nimesh A. Patel, MD
S
Sandra Alhoyek, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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