Dropless treatment for retinal detachment surgery
Dropless Pars Plana Vitrectomy Study
This study is testing if a new dropless treatment during retinal detachment surgery can work just as well as the traditional method that requires eye drops after surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 168 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Massachusetts Eye and Ear Infirmary Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05331664 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of a dropless approach using subtenon triamcinolone acetonide during surgery against a traditional regimen that includes postoperative eye drops for patients undergoing pars plana vitrectomy for rhegmatogenous retinal detachment. It is a non-inferiority, single-center, randomized, controlled, open-label trial involving two groups of patients: one receiving postoperative eye drops and the other receiving only the intraoperative injection. The study will assess postoperative inflammation and recovery outcomes to determine if the dropless method is as effective as the conventional approach.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with primary rhegmatogenous retinal detachment requiring pars plana vitrectomy.
Not a fit: Patients with a history of prior vitreoretinal surgery or those requiring additional ocular procedures will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could simplify postoperative care and improve patient compliance by eliminating the need for eye drops.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in reducing postoperative complications with dropless techniques.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Massachusetts Eye and Ear — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Nimesh A. Patel, MD — Massachusetts Eye and Ear
- Study coordinator: Nimesh A. Patel, MD
- Email: nimesh_patel2@meei.harvard.edu
- Phone: 617-523-7900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.