Clinical trial
Dropless Pars Plana Vitrectomy Study
Name
2022P000046
Description
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.
Trial arms
Trial start
2022-07-25
Estimated PCD
2025-07-25
Trial end
2026-01-30
Status
Recruiting
Phase
Early phase I
Treatment
Pars plana vitrectomy
Standard of care surgery
Arms:
Group 1, Group 2
Triamcinolone Acetonide 40mg/mL
Sub-tenon injection of triamcinolone acetonide (40mg/mL) at the time of surgery
Arms:
Group 2
Other names:
Kenalog-40
Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin
Antibiotic eye drop 4 times per day for 1 week after surgery
Arms:
Group 1
Other names:
Vigamox or Polytrim
Prednisolone 1%
Steroid eye drop 4 times per day tapered by one drop weekly for 4 weeks (4/3/2/1 taper) after surgery
Arms:
Group 1
Other names:
Pred forte
Atropine 1%
Eye drop daily for 1 week after surgery
Arms:
Group 1
Other names:
Atropine sulfate
Size
168
Primary endpoint
Mean anterior chamber cell
Day 7 after surgical procedure
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 168, 'type': 'ESTIMATED'}}
Updated at
2023-08-21
1 organization
4 products
1 indication
Organization
Massachusetts Eye and Ear InfirmaryProduct
Triamcinolone AcetonideIndication
Retinal DetachmentProduct
MoxifloxacinProduct
PrednisoloneProduct
Atropine