Dropless Pars Plana Vitrectomy Study

Launched by MASSACHUSETTS EYE AND EAR INFIRMARY · Apr 9, 2022

Keywords

ClinConnect Summary

The Dropless Pars Plana Vitrectomy Study is a clinical trial aimed at exploring a new approach to treating a condition called rhegmatogenous retinal detachment, which occurs when the retina is pulled away from its normal position in the eye. This study is comparing two methods: one where a medication called triamcinolone is given during surgery without the need for eye drops afterward, and another where patients use prescription eye drops after surgery. The goal is to find out if the no-eye-drop method is just as effective as the traditional method.

To be eligible for this trial, participants must have a primary rhegmatogenous retinal detachment that requires a specific type of surgery called pars plana vitrectomy. However, certain factors may disqualify individuals, such as having had previous eye surgeries or specific eye conditions like glaucoma. If you decide to participate, you can expect to receive care related to your surgery and follow-up assessments without the need for postoperative eye drops if you are in the trial group using the new method. This trial is currently recruiting participants of all ages and genders.

Gender

ALL

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