Dropless Pars Plana Vitrectomy Study

NCT ID: NCT05331664

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-25
• Study Completion Date: 2027-01-30

Brief 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.

Detailed 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.

Conditions

Rhegmatogenous Retinal Detachment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

• Subconjunctival antibiotic (cefazolin 50 mg/0.5 mL, moxifloxacin 0.5 mg/0.1 mL, or vancomycin 1 mg/0.1 mL) and subconjunctival dexamethasone (4 mg/mL) at the time of surgery
• Topical atropine 1% and antibiotic-steroid ointment (neomycin-polymyxin B-dexamethasone) at the time of surgery
• Topical moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin; 4 times per day for 1 week after surgery.
• Topical prednisolone 1% 1 drop 4 times per day tapered by one drop weekly for 4 weeks (4/3/2/1 taper)
• Topical atropine 1% daily for 1 week

Group Type: ACTIVE_COMPARATOR

Pars plana vitrectomy

Intervention Type: PROCEDURE

Standard of care surgery

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

Intervention Type: DRUG

Antibiotic eye drop 4 times per day for 1 week after surgery

Prednisolone 1%

Intervention Type: DRUG

Steroid eye drop 4 times per day tapered by one drop weekly for 4 weeks (4/3/2/1 taper) after surgery

Atropine 1%

Intervention Type: DRUG

Eye drop daily for 1 week after surgery

Group 2

• Subtenon triamcinolone acetonide (40 mg/1mLl) at the time of surgery
• Subconjunctival antibiotic (cefazolin 50 mg/0.5 mL, moxifloxacin 0.5 mg/0.1 mL, or vancomycin 1 mg/0.1 mL) and subconjunctival dexamethasone (4 mg/mL) at the time of surgery
• Topical atropine 1% and antibiotic-steroid ointment (neomycin-polymyxin B-dexamethasone) at the time of surgery
• No postoperative eye drops

Group Type: ACTIVE_COMPARATOR

Pars plana vitrectomy

Intervention Type: PROCEDURE

Standard of care surgery

Triamcinolone Acetonide 40mg/mL

Intervention Type: DRUG

Sub-tenon injection of triamcinolone acetonide (40mg/mL) at the time of surgery

Interventions

Pars plana vitrectomy

Standard of care surgery

Intervention Type: PROCEDURE

Triamcinolone Acetonide 40mg/mL

Sub-tenon injection of triamcinolone acetonide (40mg/mL) at the time of surgery

Intervention Type: DRUG

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

Antibiotic eye drop 4 times per day for 1 week after surgery

Intervention Type: DRUG

Prednisolone 1%

Steroid eye drop 4 times per day tapered by one drop weekly for 4 weeks (4/3/2/1 taper) after surgery

Intervention Type: DRUG

Atropine 1%

Eye drop daily for 1 week after surgery

Intervention Type: DRUG

Other Intervention Names

Kenalog-40; Vigamox or Polytrim; Pred forte; Atropine sulfate

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role: lead

Responsible Party

Nimesh Patel

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nimesh A. Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Eye and Ear

Locations

Massachusetts Eye and Ear

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nimesh A. Patel, MD

Role: CONTACT

nimesh_patel2@meei.harvard.edu

617-523-7900

Sandra Alhoyek, MD

Role: CONTACT

salhoyek@meei.harvard.edu

617-523-7900

Facility Contacts

Nimesh A Patel, MD

Role: primary

nimesh_patel2@meei.harvard.edu

References

Paccola L, Jorge R, Barbosa JC, Costa RA, Scott IU. Anti-inflammatory efficacy of a single posterior subtenon injection of triamcinolone acetonide versus prednisolone acetate 1% eyedrops after pars plana vitrectomy. Acta Ophthalmol Scand. 2007 Sep;85(6):603-8. doi: 10.1111/j.1600-0420.2007.00923.x. Epub 2007 Apr 24.

Reference Type: BACKGROUND

PMID: 17459031 (View on PubMed)

Brown GT, Karth PA, Hunter AA. Novel Postoperative Dropless Protocol for Micro-Incision Vitrectomy Surgery. Ophthalmic Surg Lasers Imaging Retina. 2021 Nov;52(11):587-591. doi: 10.3928/23258160-20211014-01. Epub 2021 Nov 1.

Reference Type: BACKGROUND

PMID: 34766851 (View on PubMed)

Bonfiglio V, Reibaldi M, Macchi I, Fallico M, Pizzo C, Patane C, Russo A, Longo A, Pizzo A, Cillino G, Cillino S, Vadala M, Rinaldi M, Rejdak R, Nowomiejska K, Toro MD, Avitabile T, Ortisi E. Preoperative, Intraoperative and Postoperative Corticosteroid Use as an Adjunctive Treatment for Rhegmatogenous Retinal Detachment. J Clin Med. 2020 May 21;9(5):1556. doi: 10.3390/jcm9051556.

Reference Type: BACKGROUND

PMID: 32455658 (View on PubMed)

Assil KK, Greenwood MD, Gibson A, Vantipalli S, Metzinger JL, Goldstein MH. Dropless cataract surgery: modernizing perioperative medical therapy to improve outcomes and patient satisfaction. Curr Opin Ophthalmol. 2021 Jan;32 Suppl 1:S1-S12. doi: 10.1097/ICU.0000000000000708.

Reference Type: BACKGROUND

PMID: 33273209 (View on PubMed)

Related Links

https://www.semanticscholar.org/paper/Elimination-of-Steroid-Drops-After-Vitreoretinal-Atchison-Gilca/e5b33498c8b088eb6538feb612e20b6d220705f1

A retrospective consecutive case series showing that single subconjunctival triamcinolone acetonide injection at the end of surgery may represent a reasonable alternative to requiring patients to use a steroid drop taper following vitreoretinal surgery.

Other Identifiers

2022P000046

Identifier Type: -

Identifier Source: org_study_id