Dropless Pars Plana Vitrectomy Study

Rhegmatogenous Retinal Detachment Clinical Trial

— DVS  

Official title:

Dropless Pars Plana Vitrectomy Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05331664
• Other study ID #: 2022P000046
• Status: Recruiting
• Phase: Phase 4
• Start date: July 25, 2022
• Est. completion date: January 30, 2026

Study information

• Verified date: August 2023
• Source: Massachusetts Eye and Ear Infirmary
• Contact: Nimesh A. Patel, MD
• Phone: 617-523-7900
• Email: nimesh_patel2[@]meei.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: January 30, 2026
• Est. primary completion date: July 25, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Retinal Detachment
• Rhegmatogenous Retinal Detachment

Intervention

Procedure:
• Pars plana vitrectomy
Standard of care surgery

Drug:
• Triamcinolone Acetonide 40mg/mL
Sub-tenon injection of triamcinolone acetonide (40mg/mL) at the time of surgery
• Moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin
Antibiotic eye drop 4 times per day for 1 week after surgery
• Prednisolone 1%
Steroid eye drop 4 times per day tapered by one drop weekly for 4 weeks (4/3/2/1 taper) after surgery
• Atropine 1%
Eye drop daily for 1 week after surgery

Locations

Country	Name	City	State
United States	Massachusetts Eye and Ear	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts Eye and Ear Infirmary

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean anterior chamber cell	Mean anterior chamber cell based on SUN (Standardization of Uveitis Nomenclature) criteria as measured by Slit Lamp Biomicroscopy	Day 7 after surgical procedure
Secondary	Mean anterior chamber cell	Mean anterior chamber cell based on Standardization of Uveitis Nomenclature (SUN) criteria as measured by Slit Lamp Biomicroscopy	Day 1, 30 and 90 after surgical procedure
Secondary	Need for rescue medication (corticosteroid)	Need for additional medication (corticosteroid) to control post-operative inflammation	Day 1, 7, 30 and 90 after surgical procedure
Secondary	Intraocular pressure less than 5 or more 30 mmHg	Intraocular pressure measured by applanation tonometer or tono-pen	Day 1, 7, 30 and 90 after surgical procedure
Secondary	Need for medications to reduce intraocular pressure	Need for additional medication to reduce intraocular pressure	Day 1, 7, 30 and 90 after surgical procedure
Secondary	Visual acuity	Best-corrected visual acuity measured using Snellen chart	Day 1, 7, 30 and 90 after surgical procedure
Secondary	Degree of pain	Degree of pain on a pain scale of 1-10 (0: pain free, 10: unspeakable pain)	Day 1, 7, 30 and 90 after surgical procedure
Secondary	Self-reported adherence to positioning	Assessment of self-reported adherence to positioning: "Over the past day or week, what percentage of time or number of hours per day do you think you adhered with the recommended positioning?"	Day 1 and 7 after surgical procedure
Secondary	Self-reported adherence to eye drops	Assessment of self-reported adherence to eye drops in the control group: "Over the past week or month, what percentage of your drops do you think you took correctly?"	Day 1, 7 and 30 after surgical procedure
Secondary	Progression of cataract	Evaluation of progression of cataract by Slit Lamp Biomicroscopy	Day 30 and 90 after surgical procedure
Secondary	Adverse events	Adverse Events including: Endophthalmitis, Re-detachment requiring surgery, Intraocular pressure requiring medication, Need for additional procedures, Any other adverse events	Day 1, 7, 30 and 90 after surgical procedure

External Links

•   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.