Dropless Pars Plana Vitrectomy Study

• Status: Not yet recruiting
• Trial end date: 2025-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts Eye and Ear Infirmary
• Treatments: Atropine; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Polymyxins; Prednisolone; Prednisolone acetate; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide; Trimethoprim

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

• Need for concomitant scleral buckle

• 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