RECRUITING

Dropless Pars Plana Vitrectomy Study

Conditions

Rhegmatogenous Retinal Detachment Vitrectomy Dropless Sub-tenon steroids Postoperative Inflammation Randomized clinical trial Non-inferiority trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Dropless Pars Plana Vitrectomy Study

Quick Facts

Study Start:2022-07-25

Study Completion:2026-01-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05331664

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Primary rhegmatogenous retinal detachment (mac-on or mac-off) requiring pars plana vitrectomy (23, 25 and 27-gauge)	* 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

Inclusion Criteria

Exclusion Criteria

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

* 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

Contacts and Locations

Study Contact

Nimesh A. Patel, MD

CONTACT

617-523-7900

nimesh_patel2@meei.harvard.edu

Sandra Alhoyek, MD

CONTACT

617-523-7900

salhoyek@meei.harvard.edu

Principal Investigator

Nimesh A. Patel, MD

PRINCIPAL_INVESTIGATOR

Massachusetts Eye and Ear

Study Locations (Sites)

Massachusetts Eye and Ear

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts Eye and Ear Infirmary

Nimesh A. Patel, MD, PRINCIPAL_INVESTIGATOR, Massachusetts Eye and Ear

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-25

Study Completion Date2026-01-30

Study Record Updates

Study Start Date2022-07-25

Study Completion Date2026-01-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Rhegmatogenous Retinal Detachment