Vitreoretinal SurgeryPhase 4NCT04371445
Dextenza in the Post-op Management of Vitreoretinal Surgeries
A Phase 4 study testing Dexamethasone Ophthalmic Insert and Prednisolone Acetate 1% Oph Susp in people with Vitreoretinal Surgery and Ocular Inflammation, run by The Cleveland Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitreoretinal Surgery, Ocular Inflammation, Post-operative Pain
- What is being tested?
- Dexamethasone Ophthalmic Insert and Prednisolone Acetate 1% Oph Susp
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 1 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
- Presence of any intraocular inflammation (cells and flare) in the study eye at screening/baseline
- Pain score greater than "0" on the ocular pain assessment in the study eye at screening/baseline
Show all 17Show fewer
- Active or chronic or recurrent uncontrolled ocular or systemic inflammatory disease, including diabetes
- Other ocular surgeries or procedures during the study period and/or 6 months prior
- Intraoperative complications
- Patients with history of glaucoma (defined as glaucoma requiring 2 or more drops, IOP at baseline greater than 25, or advanced optic nerve cupping). Patients with glaucoma or ocular hypertension controlled with a single drop can be enrolled.
- Patients with a known hypersensitivity to NSAIDs or steroids or any component of the study medication.
- Have used ocular, topical, or systemic NSAIDs within 7 days prior to procedure and during surgery.
- Use of intracameral or subconjunctival NSAIDs or steroids intraoperatively.
- Have used topical, ocular, inhaled or systemic steroids within 14 days prior to procedure
- Are pregnant or nursing/lactating
- Participation as a subject in any clinical study within the 30 days prior to randomization.
- Surgeries using 20 gauge or 23 gauge instruments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cole Eye Institute, Cleveland Clinic
Cleveland, Ohio, 44195
Rishi Singh, M.D, 216-445-9497, singhr@ccf.org
About this study
Official title: Intracanalicular Dexamethasone Insert for Management of Post-operative Pain and Inflammation in Patients Undergoing Vitreoretinal Surgery
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.
Read the detailed description
Topical steroids are the current standard of care for managing postoperative pain and inflammation following vitreoretinal surgery. However, topical treatments are limited by the potential for patient non-adherence and variation in drug concentrations due to the intermittent nature of application. A corticosteroid insert, placed following surgery, provides the advantages of reliable and continuous drug delivery without the need for patients to adhere to a treatment regimen. Recently, DEXTENZA®, a dexamethasone intracanalicular insert was FDA-approved for the treatment of inflammation and pain following ophthalmic surgery. DEXTENZA® is placed into the canaliculus via the lower punctum and is designed to release steroid medication for 30 days.
The data is limited regarding the safety and efficacy of DEXTENZA® for postoperative management of vitreoretinal surgery. Herein, the aim of this study is to assess the management of pain and inflammation following retinal surgery when using a dexamethasone implant compared with topical steroids.
- Conditions
- Vitreoretinal Surgery, Ocular Inflammation, Post-operative Pain, Post-Operative Inflammation
- Being tested
- Dexamethasone Ophthalmic Insert, Prednisolone Acetate 1% Oph Susp
- Keywords
- dexamethasone insert, Ocular Inflammation, Post-Operative Inflammation, Post-operative Pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone Ophthalmic InsertDrug
Also called DEXTENZA®
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 SuspDrug
Also called PRED FORTE®, OMNIPRED®
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 group | Role | What they receive |
|---|---|---|
| Intracanalicular dexamethasone insert group | Experimental | This arm will receive the DEXTENZA® insert within minutes after the completion of the surgery. Receives: Drug: Dexamethasone Ophthalmic Insert |
| Topical steroid drop group | Active comparator | 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. Receives: Drug: Prednisolone Acetate 1% Oph Susp |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 14 following surgery
Secondary outcomes (7)
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.
Measured: days 1, 3, 7, 14, and 21 following surgery
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).
Measured: days 1, 7, 14, and 21 following surgery
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.
Measured: day 21 following surgery
% of patients with rebound inflammation defined as a two-step worsening of inflammation by SUN grading.
Measured: day 21 following surgery
% of patients receiving rescue treatment.
Measured: days 1, 7, 14, and 21 following surgery
% of patients with postoperative management via telephone or electronic messaging
Measured: day 21 following surgery
The incidence and severity of ocular and non-ocular adverse events (AEs) and serious AEs between arms.
Measured: day 21 following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start1 Jun 2020
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Vitreoretinal SurgeryStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Responsible party
- Principal investigator, Katherine Talcott, The Cleveland Clinic
- Investigators
- Katherine Talcott, M.D., Principal investigator, Cole Eye Institute, Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371445
- Sponsor's protocol ID
- 4-29-2020
- Status last verified
- Jul 2026
- First submitted
- 29 Apr 2020
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Hermann MM, Ustundag C, Diestelhorst M. Electronic compliance monitoring of topical treatment after ophthalmic surgery. Int Ophthalmol. 2010 Aug;30(4):385-90. doi: 10.1007/s10792-010-9362-3. Epub 2010 Apr 7.
PubMed 20373127An JA, Kasner O, Samek DA, Levesque V. Evaluation of eyedrop administration by inexperienced patients after cataract surgery. J Cataract Refract Surg. 2014 Nov;40(11):1857-61. doi: 10.1016/j.jcrs.2014.02.037. Epub 2014 Sep 22.
PubMed 25248295Tyson SL, Bafna S, Gira JP, Goldberg DF, Jones JJ, Jones MP, Kim JK, Martel JM, Nordlund ML, Piovanetti-Perez IK, Singh IP, Metzinger JL, Mulani D, Sane S, Talamo JH, Goldstein MH; Dextenza Study Group. Multicenter randomized phase 3 study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery. J Cataract Refract Surg. 2019 Feb;45(2):204-212. doi: 10.1016/j.jcrs.2018.09.023. Epub 2018 Oct 24.
PubMed 30367938Gira JP, Sampson R, Silverstein SM, Walters TR, Metzinger JL, Talamo JH. Evaluating the patient experience after implantation of a 0.4 mg sustained release dexamethasone intracanalicular insert (Dextenza): results of a qualitative survey. Patient Prefer Adherence. 2017 Mar 8;11:487-494. doi: 10.2147/PPA.S126283. eCollection 2017.
PubMed 28331295Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016/j.ajo.2005.03.057.
PubMed 16196117
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracanalicular Dexamethasone Insert for Management of Post-operative Pain and Inflammation in Patients Undergoing Vitreoretinal Surgery
- ClinicalTrials.gov ID
- NCT04371445
- Acronym / sponsor ID
- 4-29-2020
- Conditions
- Vitreoretinal Surgery, Ocular Inflammation, Post-operative Pain, Post-Operative Inflammation
- Keywords
- dexamethasone insert, Ocular Inflammation, Post-Operative Inflammation, Post-operative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Ocular Therapeutix, Inc.
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 1 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Topical steroids are the current standard of care for managing postoperative pain and inflammation following vitreoretinal surgery. However, topical treatments are limited by the potential for patient non-adherence and variation in drug concentrations due to the intermittent nature of application. A corticosteroid insert, placed following surgery, provides the advantages of reliable and continuous drug delivery without the need for patients to adhere to a treatment regimen. Recently, DEXTENZA®, a dexamethasone intracanalicular insert was FDA-approved for the treatment of inflammation and pain following ophthalmic surgery. DEXTENZA® is placed into the canaliculus via the lower punctum and is designed to release steroid medication for 30 days.
The data is limited regarding the safety and efficacy of DEXTENZA® for postoperative management of vitreoretinal surgery. Herein, the aim of this study is to assess the management of pain and inflammation following retinal surgery when using a dexamethasone implant compared with topical steroids.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracanalicular dexamethasone insert group | Experimental | Drug: Dexamethasone Ophthalmic InsertThis arm will receive the DEXTENZA® insert within minutes after the completion of the surgery. |
| Topical steroid drop group | Active comparator | Drug: Prednisolone Acetate 1% Oph SuspThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
- Presence of any intraocular inflammation (cells and flare) in the study eye at screening/baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone Ophthalmic InsertAlso: DEXTENZA®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. | Drug | Intracanalicular dexamethasone insert group |
| Prednisolone Acetate 1% Oph SuspAlso: PRED FORTE®, OMNIPRED®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. | Drug | Topical steroid drop group |
Primary outcome
To assess control of inflammation following the vitreoretinal surgical procedure.
Time frame: day 14 following surgery
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
7 secondary outcomes
The patient reporting of pain following surgery using visual analog pain scale at days 1, 3, 7, 14, and 21 following surgery.
Time frame: days 1, 3, 7, 14, and 21 following surgery
Inflammation assessed on Anterior Segment OCT by masked grading at days 1, 7, 14, and 21 following surgery.
Time frame: days 1, 7, 14, and 21 following surgery
Mean change in Best Corrected Visual Acuity (BCVA) from baseline to day 21 following surgery.
Time frame: day 21 following surgery
% of patients with rebound inflammation defined as a two-step worsening of inflammation by SUN grading.
Time frame: day 21 following surgery
% of patients receiving rescue treatment.
Time frame: days 1, 7, 14, and 21 following surgery
% of patients with postoperative management via telephone or electronic messaging
Time frame: day 21 following surgery
The incidence and severity of ocular and non-ocular adverse events (AEs) and serious AEs between arms.
Time frame: day 21 following surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Background: PubMed 20373127Hermann MM, Ustundag C, Diestelhorst M. Electronic compliance monitoring of topical treatment after ophthalmic surgery. Int Ophthalmol. 2010 Aug;30(4):385-90. doi: 10.1007/s10792-010-9362-3. Epub 2010 Apr 7.
- Background: PubMed 25248295An JA, Kasner O, Samek DA, Levesque V. Evaluation of eyedrop administration by inexperienced patients after cataract surgery. J Cataract Refract Surg. 2014 Nov;40(11):1857-61. doi: 10.1016/j.jcrs.2014.02.037. Epub 2014 Sep 22.
- Background: PubMed 30367938Tyson SL, Bafna S, Gira JP, Goldberg DF, Jones JJ, Jones MP, Kim JK, Martel JM, Nordlund ML, Piovanetti-Perez IK, Singh IP, Metzinger JL, Mulani D, Sane S, Talamo JH, Goldstein MH; Dextenza Study Group. Multicenter randomized phase 3 study of a sustained-release intracanalicular dexamethasone insert for treatment of ocular inflammation and pain after cataract surgery. J Cataract Refract Surg. 2019 Feb;45(2):204-212. doi: 10.1016/j.jcrs.2018.09.023. Epub 2018 Oct 24.
- Background: PubMed 28331295Gira JP, Sampson R, Silverstein SM, Walters TR, Metzinger JL, Talamo JH. Evaluating the patient experience after implantation of a 0.4 mg sustained release dexamethasone intracanalicular insert (Dextenza): results of a qualitative survey. Patient Prefer Adherence. 2017 Mar 8;11:487-494. doi: 10.2147/PPA.S126283. eCollection 2017.
- Background: PubMed 16196117Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016/j.ajo.2005.03.057.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine Talcott, M.D. principal investigator
Cole Eye Institute, Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone Ophthalmic Insert and Prednisolone Acetate 1% Oph Susp in people with Vitreoretinal Surgery and Ocular Inflammation, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine Talcott, M.D. (440 988-4040, talcotk@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess control of inflammation following the vitreoretinal surgical procedure. (time frame: day 14 following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04371445, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.