Dropless Pars Plana Vitrectomy Study

Phase

Condition

Retina

Macular Degeneration

Treatment

Atropine 1%

Pars plana vitrectomy

Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin

Clinical Study ID

NCT05331664

2022P000046

Ages > 40
All Genders
Accepts Healthy Volunteers

Study 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

Inclusion Criteria:

Primary rhegmatogenous retinal detachment (mac-on or mac-off) requiring pars planavitrectomy (23, 25 and 27-gauge)

Exclusion

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 lasersurgery) 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 theoperation 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

Study Design

Atropine 1%

July 25, 2022

January 30, 2027

Study Description

This is a non-inferiority, single-center, randomized, controlled, open-label clinical trial. Investigators will recruit patients that present to their clinic or emergency department with newly diagnosed mac-on or mac-off rhegmatogenous retinal detachment. Patients will be randomized to one of the following groups:

Group 1: A total of 84 study subjects (84 eyes) will receive topical antibiotic qid for one week after surgery, topical prednisolone 1% qid tapered by one drop weekly for four weeks (4/3/2/1 taper), and topical atropine 1% daily for one week.
Group 2: A total of 84 study subjects (84 eyes) will receive sub-tenon injection of triamcinolone acetonide (40 mg/mL) at the time of surgery, with no post-operative eye drops.

Both groups will receive subconjunctival injection of antibiotic (cefazolin 50 mg/0.5 ml, moxifloxacin 0.5 mg/0.1 ml, or vancomycin 1 mg/0.1 ml) and subconjunctival injection of dexamethasone (4 mg/ml) at the time of surgery, as well as atropine 1% and antibiotic-steroid ointment (neomycin-polymyxin B-dexamethasone) at the time of surgery.

Connect with a study center

Massachusetts Eye and Ear
Boston, Massachusetts 02114
United States
Active - Recruiting

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