Health TrialsbyHealthPanel

Dextenza in the Post-op Management of Vitreoretinal Surgeries

ConditionsVitreoretinal SurgeryOcular InflammationPost-operative PainPost-Operative Inflammation
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cleveland Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men and women >18 years old

Planning to undergo vitreoretinal surgery with the procedure type of pars plana vitrectomy for either the indication of macular hole, epiretinal membrane removal, or vitreomacular traction.

Disqualifiers

Patients undergoing combined cataract or glaucoma procedure, intraocular lens exchange, scleral buckle, and/or implant of a drug delivery system

History of complications, trauma, adverse events, disease in nasolacrimal region, including dacryocystitis, canaliculitis in either eye

Structural lid abnormalities such as ectropion or entropion in surgical eye

Ongoing use of systemic narcotic pain relievers

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Intracanalicular dexamethasone insert groupExperimental treatment 1 intervention
Group B: Topical steroid drop groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

To assess control of inflammation following the vitreoretinal surgical procedure.

Percentage of patients with Inflammation following surgery as assessed from 0-4+ cell and flare based on the Standardization of Uveitis Nomenclature \[SUN\] Working Group grading scheme at day 14

Time frame
day 14 following surgery

Secondary outcomes

1

The patient reporting of pain following surgery using visual analog pain scale at days 1, 3, 7, 14, and 21 following surgery.

Pain following surgery will be measured using a scale from 0 to10 (0 = no pain, 10 = severe pain that prevents performing activities of daily living). Higher scores mean a worse outcome.

Time frame
days 1, 3, 7, 14, and 21 following surgery
2

Inflammation assessed on Anterior Segment OCT by masked grading at days 1, 7, 14, and 21 following surgery.

Anterior segment will be assessed using a continuous variable (cells/mm3).

Time frame
days 1, 7, 14, and 21 following surgery
3

Mean change in Best Corrected Visual Acuity (BCVA) from baseline to day 21 following surgery.

BCVA was assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) method.

Time frame
day 21 following surgery
4

% of patients with rebound inflammation defined as a two-step worsening of inflammation by SUN grading.

Time frame
day 21 following surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Cleveland Clinic

Lead sponsor

Ocular Therapeutix, Inc.

Collaborator

Source ClinicalTrials.gov
Apply now