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Recruiting NCT05331664

Dropless Pars Plana Vitrectomy Study

Conditions: Rhegmatogenous Retinal Detachment

Sex: All
Ages: 40 Years – N/A
Healthy volunteers: Yes
Phase: PHASE4
Enrollment: 168
Sponsor: Massachusetts Eye and Ear Infirmary

Location: Massachusetts Eye and Ear Boston Massachusetts

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05331664). StuddyBuddy aggregates publicly available trial information.