Electronic compliance monitoring of topical treatment after ophthalmic surgery.
Manuel Marcel Hermann, Can Ustündag, Michael Diestelhorst
https://pubmed.ncbi.nlm.nih.gov/20373127Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID04371445
Intracanalicular Dexamethasone Insert for Postoperative Pain and Inflammation Management in Vitreoretinal Surgery
Led by The Cleveland Clinic · Updated on 2026-02-10
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The Cleveland Clinic
Lead Sponsor
O
Ocular Therapeutix, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the management of pain and inflammation following vitreoretinal surgery using two different treatment approaches: a dexamethasone intracanalicular insert and standard topical steroid eye drops. The study focuses on patients 18 years and older undergoing pars plana vitrectomy for conditions like macular hole, epiretinal membrane removal, or vitreomacular traction. The goal is to compare how well these treatments control inflammation and pain after surgery. The study has two randomized groups. One group receives the DEXTENZA® dexamethasone insert placed into the lower eyelid canaliculus shortly after surgery, which releases steroid medication continuously for up to 30 days. The other group uses prednisolone acetate 1% eye drops four times daily for the first week after surgery. Both groups also receive standard topical antibiotic treatments. This study is conducted under a phase 4 design. Participants will be monitored for inflammation and pain at several time points: days 1, 3, 7, 14, and 21 after surgery. Assessments include inflammation control, pain levels using a visual scale, eye imaging, visual acuity changes, and the need for additional treatments. Researchers will also track adverse events and methods of postoperative management like telephone or electronic follow-up. The total follow-up period extends to 21 days post-surgery to assess outcomes and safety.
CONDITIONS
Brief Title
Dextenza in the Post-op Management of Vitreoretinal Surgeries
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Men and women older than 18 years
- Planning to undergo pars plana vitrectomy for macular hole, epiretinal membrane removal, or vitreomacular traction
You will not qualify if you...
- Undergoing combined cataract or glaucoma procedures, intraocular lens exchange, scleral buckle, or drug delivery system implant
- History of complications or disease in the nasolacrimal region, including dacryocystitis or canaliculitis
- Structural lid abnormalities such as ectropion or entropion in the surgical eye
- Current use of systemic narcotic pain relievers
- Presence of intraocular inflammation or any eye pain greater than zero at baseline
- Active, chronic, or uncontrolled ocular or systemic inflammatory diseases, including diabetes
- Other ocular surgeries within 6 months before or during the study
- Intraoperative complications
- History of glaucoma requiring two or more drops, baseline intraocular pressure over 25, or advanced optic nerve damage
- Known hypersensitivity to NSAIDs, steroids, or study medication components
- Use of ocular, topical, systemic, or inhaled NSAIDs within 7 days prior or during surgery
- Use of steroids topically, ocularly, inhaled, or systemically within 14 days prior to surgery
- Pregnant or nursing/lactating women
- Participation in another clinical study within 30 days prior to randomization
- Surgeries using 20 gauge or 23 gauge instruments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery
Duration - 1 day
Participants undergo vitreoretinal surgery to treat macular hole, epiretinal membrane removal, or vitreomacular traction.
1 visit (in-person)
Treatment
Duration - 30 days
Participants receive either the DEXTENZA® dexamethasone intracanalicular insert placed within minutes after surgery or prednisolone acetate 1% eye drops used 4 times daily for 30 days to manage postoperative pain and inflammation.
Follow-up visits on days 1, 3, 7, 14, and 21 after surgery
Follow-up
Duration - Up to 21 days after surgery
Participants are monitored for pain, inflammation, visual acuity, and safety outcomes after treatment ends.
Follow-up visits on days 14 and 21 after surgery
Trial Site Locations
Total: 1 location
1
Cole Eye Institute, Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
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Research Team
K
Katherine Talcott, M.D.
A
Angela Meador, MHA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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