NCT05331664 Dropless Pars Plana Vitrectomy Study
| NCT ID | NCT05331664 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Massachusetts Eye and Ear Infirmary |
| Condition | Rhegmatogenous Retinal Detachment |
| Study Type | INTERVENTIONAL |
| Enrollment | 168 participants |
| Start Date | 2022-07-25 |
| Primary Completion | 2026-07-25 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 168 participants in total. It began in 2022-07-25 with a primary completion date of 2026-07-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Contact & Investigator
Nimesh A. Patel, MD
PRINCIPAL INVESTIGATOR
Massachusetts Eye and Ear
Frequently Asked Questions
Who can join the NCT05331664 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Rhegmatogenous Retinal Detachment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05331664 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05331664 currently recruiting?
Yes, NCT05331664 is actively recruiting participants. Contact the research team at nimesh_patel2@meei.harvard.edu for enrollment information.
Where is the NCT05331664 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05331664 clinical trial?
NCT05331664 is sponsored by Massachusetts Eye and Ear Infirmary. The principal investigator is Nimesh A. Patel, MD at Massachusetts Eye and Ear. The trial plans to enroll 168 participants.