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Dropless Pars Plana Vitrectomy Study (DVS)

Primary Purpose

Rhegmatogenous Retinal Detachment

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Pars plana vitrectomy

Triamcinolone Acetonide 40mg/mL

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

Prednisolone 1%

Atropine 1%

About this trial

This is an interventional treatment trial for Rhegmatogenous Retinal Detachment focused on measuring Vitrectomy, Dropless, Sub-tenon steroids, Postoperative, Inflammation, Randomized clinical trial, Non-inferiority trial

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Massachusetts Eye and EarRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group 1

Group 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Mean anterior chamber cell

Mean anterior chamber cell based on SUN (Standardization of Uveitis Nomenclature) criteria as measured by Slit Lamp Biomicroscopy

Secondary Outcome Measures

Mean anterior chamber cell

Mean anterior chamber cell based on Standardization of Uveitis Nomenclature (SUN) criteria as measured by Slit Lamp Biomicroscopy

Need for rescue medication (corticosteroid)

Need for additional medication (corticosteroid) to control post-operative inflammation

Intraocular pressure less than 5 or more 30 mmHg

Intraocular pressure measured by applanation tonometer or tono-pen

Need for medications to reduce intraocular pressure

Need for additional medication to reduce intraocular pressure

Visual acuity

Best-corrected visual acuity measured using Snellen chart

Degree of pain

Degree of pain on a pain scale of 1-10 (0: pain free, 10: unspeakable pain)

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?"

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?"

Progression of cataract

Evaluation of progression of cataract by Slit Lamp Biomicroscopy

Adverse events

Adverse Events including: Endophthalmitis, Re-detachment requiring surgery, Intraocular pressure requiring medication, Need for additional procedures, Any other adverse events

Full Information

NCT ID

NCT05331664

First Posted

April 9, 2022

Last Updated

August 16, 2023

Sponsor

Massachusetts Eye and Ear Infirmary

1. Study Identification

Unique Protocol Identification Number

NCT05331664

Brief Title

Dropless Pars Plana Vitrectomy Study

Acronym

DVS

Official Title

Dropless Pars Plana Vitrectomy Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 25, 2022 (Actual)

Primary Completion Date

July 25, 2025 (Anticipated)

Study Completion Date

January 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts Eye and Ear Infirmary

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rhegmatogenous Retinal Detachment

Keywords

Vitrectomy, Dropless, Sub-tenon steroids, Postoperative, Inflammation, Randomized clinical trial, Non-inferiority trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Active Comparator

Arm Description

Arm Title

Group 2

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Pars plana vitrectomy

Intervention Description

Standard of care surgery

Intervention Type

Drug

Intervention Name(s)

Triamcinolone Acetonide 40mg/mL

Other Intervention Name(s)

Kenalog-40

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

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

Other Intervention Name(s)

Vigamox or Polytrim

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Prednisolone 1%

Other Intervention Name(s)

Pred forte

Intervention Description

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

Intervention Name(s)

Atropine 1%

Other Intervention Name(s)

Atropine sulfate

Intervention Description

Eye drop daily for 1 week after surgery

Primary Outcome Measure Information:

Title

Mean anterior chamber cell

Description

Mean anterior chamber cell based on SUN (Standardization of Uveitis Nomenclature) criteria as measured by Slit Lamp Biomicroscopy

Time Frame

Day 7 after surgical procedure

Secondary Outcome Measure Information:

Title

Mean anterior chamber cell

Description

Mean anterior chamber cell based on Standardization of Uveitis Nomenclature (SUN) criteria as measured by Slit Lamp Biomicroscopy

Time Frame

Day 1, 30 and 90 after surgical procedure

Title

Need for rescue medication (corticosteroid)

Description

Need for additional medication (corticosteroid) to control post-operative inflammation

Time Frame

Day 1, 7, 30 and 90 after surgical procedure

Title

Intraocular pressure less than 5 or more 30 mmHg

Description

Intraocular pressure measured by applanation tonometer or tono-pen

Time Frame

Day 1, 7, 30 and 90 after surgical procedure

Title

Need for medications to reduce intraocular pressure

Description

Need for additional medication to reduce intraocular pressure

Time Frame

Day 1, 7, 30 and 90 after surgical procedure

Title

Visual acuity

Description

Best-corrected visual acuity measured using Snellen chart

Time Frame

Day 1, 7, 30 and 90 after surgical procedure

Title

Degree of pain

Description

Degree of pain on a pain scale of 1-10 (0: pain free, 10: unspeakable pain)

Time Frame

Day 1, 7, 30 and 90 after surgical procedure

Title

Self-reported adherence to positioning

Description

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?"

Time Frame

Day 1 and 7 after surgical procedure

Title

Self-reported adherence to eye drops

Description

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?"

Time Frame

Day 1, 7 and 30 after surgical procedure

Title

Progression of cataract

Description

Evaluation of progression of cataract by Slit Lamp Biomicroscopy

Time Frame

Day 30 and 90 after surgical procedure

Title

Adverse events

Description

Adverse Events including: Endophthalmitis, Re-detachment requiring surgery, Intraocular pressure requiring medication, Need for additional procedures, Any other adverse events

Time Frame

Day 1, 7, 30 and 90 after surgical procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nimesh A. Patel, MD

Phone

617-523-7900

nimesh_patel2@meei.harvard.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Sandra Alhoyek, MD

Phone

617-523-7900

salhoyek@meei.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nimesh A. Patel, MD

Organizational Affiliation

Massachusetts Eye and Ear

Official's Role

Principal Investigator

Facility Information:

Facility Name

Massachusetts Eye and Ear

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nimesh A Patel, MD

nimesh_patel2@meei.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

17459031

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.

Results Reference

background

PubMed Identifier

34766851

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.

Results Reference

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PubMed Identifier

32455658

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.

Results Reference

background

PubMed Identifier

33273209

Citation

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.

Results Reference

background

Links:

URL

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

Description

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.

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Dropless Pars Plana Vitrectomy Study

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