Dextenza in the Post-op Management of Vitreoretinal Surgeries

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
The Cleveland Clinic
Study ID
NCT04371445
Phase
PHASE4
Status
Recruiting
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Conditions

  • Ocular Inflammation
  • Post-Operative Inflammation
  • Post-operative Pain
  • Vitreoretinal Surgery

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone Ophthalmic Insert — DRUG
    DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care including topical antibiotics.
  • Prednisolone Acetate 1% Oph Susp — DRUG
    Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care including topical antibiotics.

Study Details

This study will assess the control of inflammation at days 1, 7, 14, and 21 days following the vitreoretinal surgical procedure analyzing two randomized study arms: Intracanalicular dexamethasone insert group or topical steroid drop group. Patients must be 18 years of age and older, of any race and either sex, requiring surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.

Key Dates

Start date
Jun 1, 2020
Status verified
Feb 2026
Primary completion
May 1, 2026
Completion
May 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intracanalicular dexamethasone insert group
    This arm will receive the DEXTENZA® insert within minutes after the completion of the surgery.
  • Active Comparator: Topical steroid drop group
    This arm will receive the prescription for daily prednisolone acetate 1% eye drops 4 times a day for the first week following the procedure, starting on the day of surgery.

Primary Outcome Measure

To assess control of inflammation following the vitreoretinal surgical procedure. [ Time Frame: day 14 following surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cole Eye Institute, Cleveland ClinicClevelandOhio44195
Rishi Singh, M.D
[email protected]
216-445-9497

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By research site
Cole Eye Institute, Cleveland Clinic· Cleveland, OH

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