Corneal EdemaPhase 4NCT05626478

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery

A Phase 4 study testing Dextenza 0.4Mg Ophthalmic Insert, Prednisolone Acetate 1% Oph Susp and Prolensa 0.07% Ophthalmic Solution in people with Corneal Edema and Corneal Defect, run by Nicole Fram M.D. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Corneal Edema, Corneal Defect, Anterior Chamber Inflammation
What is being tested?: Dextenza 0.4Mg Ophthalmic Insert, Prednisolone Acetate 1% Oph Susp and Prolensa 0.07% Ophthalmic Solution
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 1 Jun 2023to 5 Feb 2025
Phase: Phase 4
Are there results?: None posted in the registry

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

Diagnosed with clinically significant cataract and are planning to undergo non-complicated Clear Cornea Incision Cataract Extraction with Posterior Capsule IntraOcular Lens in one or both eyes
Are willing and able to comply with clinic visits and study related procedures
Are willing and able to sign the informed consent form

Who cannot join

Under the age of 18 at the time of signing the Informed Consent Form
Pregnant or planning to become pregnant during the trial period
Have visual acuity potential of less than 20/30 as recorded by a Retinal Acuity Meter or Potential Acuity Meter glare testing
Have active infectious systemic disease
Have active infectious ocular or extraocular disease
Have punctal plug in the study eye

Show all 18Show fewer

Have obstructed nasolacrimal duct in the study eye(s) (dacryocystitus)
Have known hypersensitivity to dexamethasone or are a known steroid responder
Have a history of ocular inflammation or macular edema
Has history of Laser Vision Correction (LASIK, PhotoRefractive Keratectomy) in the operated eye
Are currently being treated with immunomodulating agents in the study eye
Are currently being treated with immunosuppressants and/or oral steroids
Are currently being treated with corticosteroid implant (i.e Ozurdex)
Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye
Have a history of complete punctal occlusion in one or both punctum
Currently using topical ophthalmic steroid medications
Are unwilling or unable to comply with the study protocol
Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment

Trial locations and contacts

1 site in 1 country.

United States1 site

Advanced Vision Care
Los Angeles, California, 90067

Other trials in United States

About this study

Official title: Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt in Conjunction With Topical Drop Regimen Treating Pain and inflamMation Following Cataract Surgery Compared to SOC Topical Drop Regimen

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery

Read the detailed description

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt Treating Pain, and inflamMation Following Cataract Surgery Compared to Topical Prednisolone Acetate 1%.

Conditions: Corneal Edema, Corneal Defect, Anterior Chamber Inflammation, Ocular Pain, Corneal Staining, Visual Outcome
Being tested: Dextenza 0.4Mg Ophthalmic Insert, Prednisolone Acetate 1% Oph Susp, Prolensa 0.07% Ophthalmic Solution
Medical subject headings: Corneal Edema, Eye Pain, Macular Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dextenza 0.4Mg Ophthalmic InsertDrug
Also called Dexamethasone 0.4mg
DEXTENZA 0.4Mg Ophthalmic Insert is a corticosteroid (to decrease inflammation) intracanalicular insert placed in the punctum, a natural opening in the eye lid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives.
Prednisolone Acetate 1% Oph SuspDrug
Prednisolone Acetate 1% is a corticosteroid (to decrease inflammation) and being used as a topical drop after cataract surgery per Standard Of Care.
Prolensa 0.07% Ophthalmic SolutionDrug
Prolensa 0.07% is a NSAID (to decrease inflammation, swelling and pain) and is being used as a topical drop after cataract surgery per Standard Of Care.

Study groups in NCT05626478
Study group	Role	What they receive
Arm 1 - Cataract surgery gtt regimen per SOC	Active comparator	Following cataract surgery (without Dextenza 0.4mg insert) patients will receive: Prednisolone Acetate 1% QID X 2 Weeks, then BID x 2 weeks and stop / Prolensa 0.07% QD X 4 Weeks and stop. Receives: Drug: Prednisolone Acetate 1% Oph Susp; Drug: Prolensa 0.07% Ophthalmic Solution
Arm 2 - Cataract surgery with Dextenza and less frequency of gtt regimen	Experimental	Following cataract surgery with DEXTENZA 0.4mg insert, patients will receive: Prolensa 0.07% QD X 4 Weeks and stop Receives: Drug: Dextenza 0.4Mg Ophthalmic Insert; Drug: Prolensa 0.07% Ophthalmic Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean change in anterior chamber inflammation (Cell and Flare) scores
Measured by SUN (Standardization on Uveitis Nomenclature) grading scale: absence of cell to be defined as a grade of 0-0.5 and absence of flare to be defined as a grade of: 0-1. 0-4 score scale, higher scores mean a worse outcome. 0-1 Absent, 1-2 Mild, 2-3 Moderate, 4 Severe.
Measured: Assessed on Days 1,7,30,90
Mean change in pain score
Measured with the visual analog scale (VAS); between 0 and 100; 0 meaning no pain and 100 meaning worst pain possible, higher scores mean a worse outcome. 0-10 Absent, 11-30 Mild, 31-70 Moderate, 71-100 Severe.
Measured: Assessed on Day 1,7, 30 and 90

Secondary outcomes (3)

Visual outcome (Best Corrected Visual Acuity)
Measured by ETDRS (Early Treatment Diabetic Retinopathy Study) chart. 0-70 letter read score, higher scores mean a better outcome.
Measured: Assessed on Day 1,7, 30 and 90
Absence of CME (Cystoid Macular Edema)
Macular thickness measured by OCT (Optical Coherence Tomography) and compared to the preop measurements, higher scores (>over 50 microns) mean a worse outcome.
Measured: Assessed on Day 90
Mean change in corneal staining
measured by the National Eye Institute 0-4 score scale, higher scores mean a worse outcome. 0-1 Mild, 2-3 Moderate, 4 Severe. Total score 0-5 Mild, 6-15 Moderate, 16-20 Severe.
Measured: Assessed on Day 7, 30 and 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20235 Feb 2025

First posted23 Nov 2022
Study start1 Jun 2023
Primary completion5 Feb 2025
Study completion5 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Corneal EdemaStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: In patient who undergo cataract surgery, subjects will be randomized to 2 arms and be followed for a period of 3 months. Arm 1- control group, 25 subjects will receive Prednisolone Acetate 1% QID x 2 weeks then BID x 2 weeks. Arm 2 - study group, 25 subjects will receive Dextenza 0.4mg insert
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05626478
Sponsor's protocol ID: AVC-003
Status last verified: Feb 2026
First submitted: 8 Nov 2022
Last updated: 20 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

ARMALY MF. EFFECT OF CORTICOSTEROIDS ON INTRAOCULAR PRESSURE AND FLUID DYNAMICS. II. THE EFFECT OF DEXAMETHASONE IN THE GLAUCOMATOUS EYE. Arch Ophthalmol. 1963 Oct;70:492-9. doi: 10.1001/archopht.1963.00960050494011. No abstract available.
PubMed 14078871
Patel SB, Reddy NK, He YG. TOXIC POSTERIOR SEGMENT SYNDROME AFTER DROPLESS CATARACT SURGERY WITH COMPOUNDED TRIAMCINOLONE-MOXIFLOXACIN. Retina. 2020 Mar;40(3):446-455. doi: 10.1097/IAE.0000000000002450.
PubMed 30689622
Freire FS, Lang R, Abalem MF, Johnson MW. RETINAL DEPOSITS OF TRIAMCINOLONE-MOXIFLOXACIN AFTER DROPLESS CATARACT SURGERY. Retin Cases Brief Rep. 2023 Sep 1;17(5):577-580. doi: 10.1097/ICB.0000000000001243.
PubMed 37643045
Jabs 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
Ibach MJ, Zimprich L, Wallin DD, Olevson C, Puls-Boever K, Thompson V. In Clinic Optometrist Insertion of Dextenza (Dexamethasone Ophthalmic Insert 0.4mg) Prior to Cataract Surgery: The PREPARE Study. Clin Ophthalmol. 2022 Aug 13;16:2609-2615. doi: 10.2147/OPTH.S374405. eCollection 2022.
PubMed 35992569
Ibach MJ, Shafer BM, Wallin DD, Puls-Boever KR, Thompson VM, Berdahl JP. The Effectiveness and Safety of Dextenza 0.4 mg for the Treatment of Postoperative Inflammation and Pain in Patients After Photorefractive Keratectomy: The RESTORE Trial. J Refract Surg. 2021 Sep;37(9):590-594. doi: 10.3928/1081597X-20210610-05. Epub 2021 Sep 1.
PubMed 34506241
Alsetri H, Fram N, Shiler O. Evaluating a Sustained-Release Dexamethasone Insert as Adjunctive Therapy for Inflammation and Pain Post-Corneal Transplantation. Clin Ophthalmol. 2024 Jul 16;18:2083-2091. doi: 10.2147/OPTH.S466118. eCollection 2024.
PubMed 39051020
Fram N, Alsetri H, Shiler O, Paterno PJ, Cabang J. Retrospective Study of a Sustained-Release Intracanalicular Dexamethasone Insert for Treatment of Ocular Inflammation After Cataract and Corneal Surgery. Clin Ophthalmol. 2022 Dec 10;16:4065-4074. doi: 10.2147/OPTH.S386702. eCollection 2022.
PubMed 36532822
Shapiro JN, Armenti ST, Levine H, Hood CT, Mian SI. Dexamethasone Intracanalicular Insert versus Standard Topical Steroids for the Prophylaxis of Inflammation after Cataract Surgery. Am J Ophthalmol. 2024 Dec;268:174-180. doi: 10.1016/j.ajo.2024.07.030. Epub 2024 Jul 31.
PubMed 39089352
Tyson 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 30367938
Walters T, Endl M, Elmer TR, Levenson J, Majmudar P, Masket S. Sustained-release dexamethasone for the treatment of ocular inflammation and pain after cataract surgery. J Cataract Refract Surg. 2015 Oct;41(10):2049-59. doi: 10.1016/j.jcrs.2015.11.005.
PubMed 26703279
Donnenfeld ED, Hovanesian JA, Malik AG, Wong A. A Randomized, Prospective, Observer-Masked Study Comparing Dropless Treatment Regimen Using Intracanalicular Dexamethasone Insert, Intracameral Ketorolac, and Intracameral Moxifloxacin versus Conventional Topical Therapy to Control Postoperative Pain and Inflammation in Cataract Surgery. Clin Ophthalmol. 2023 Aug 15;17:2349-2356. doi: 10.2147/OPTH.S422502. eCollection 2023.
PubMed 37600148
Nassiri S, Hwang FS, Kim J, LeClair B, Yoon E, Pham M, Rauser ME. Comparative analysis of intravitreal triamcinolone acetonide-moxifloxacin versus standard perioperative eyedrops in cataract surgery. J Cataract Refract Surg. 2019 Jun;45(6):760-765. doi: 10.1016/j.jcrs.2018.12.019. Epub 2019 Mar 6.
PubMed 30850125
Chang DT, Herceg MC, Bilonick RA, Camejo L, Schuman JS, Noecker RJ. Intracameral dexamethasone reduces inflammation on the first postoperative day after cataract surgery in eyes with and without glaucoma. Clin Ophthalmol. 2009;3:345-55. doi: 10.2147/opth.s5730. Epub 2009 Jun 2.
PubMed 19668589
Kuriakose RK, Cho S, Nassiri S, Hwang FS. Comparative Outcomes of Standard Perioperative Eye Drops, Intravitreal Triamcinolone Acetonide-Moxifloxacin, and Intracameral Dexamethasone-Moxifloxacin-Ketorolac in Cataract Surgery. J Ophthalmol. 2022 Jul 19;2022:4857696. doi: 10.1155/2022/4857696. eCollection 2022.
PubMed 35903174

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Corneal Edema trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt in Conjunction With Topical Drop Regimen Treating Pain and inflamMation Following Cataract Surgery Compared to SOC Topical Drop Regimen
ClinicalTrials.gov ID: NCT05626478
Acronym / sponsor ID: AVC-003
Conditions: Corneal Edema, Corneal Defect, Anterior Chamber Inflammation, Ocular Pain, Corneal Staining, Visual Outcome
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Nicole Fram M.D.University, hospital or other
Study start: 1 Jun 2023 (actual)
Primary completion: 5 Feb 2025 (actual)
Study completion: 5 Feb 2025 (actual)
First posted: 23 Nov 2022 (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.

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt, Following Cataract Surgery

Detailed description

Assessing eFficacy and Safety of DEXTENZA 0.4 mg inseRt Treating Pain, and inflamMation Following Cataract Surgery Compared to Topical Prednisolone Acetate 1%.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: In patient who undergo cataract surgery, subjects will be randomized to 2 arms and be followed for a period of 3 months. Arm 1- control group, 25 subjects will receive Prednisolone Acetate 1% QID x 2 weeks then BID x 2 weeks. Arm 2 - study group, 25 subjects will receive Dextenza 0.4mg insert

Arm	Type	Receives
Arm 1 - Cataract surgery gtt regimen per SOC	Active comparator	Drug: Prednisolone Acetate 1% Oph Susp, Drug: Prolensa 0.07% Ophthalmic SolutionFollowing cataract surgery (without Dextenza 0.4mg insert) patients will receive: Prednisolone Acetate 1% QID X 2 Weeks, then BID x 2 weeks and stop / Prolensa 0.07% QD X 4 Weeks and stop.
Arm 2 - Cataract surgery with Dextenza and less frequency of gtt regimen	Experimental	Drug: Dextenza 0.4Mg Ophthalmic Insert, Drug: Prolensa 0.07% Ophthalmic SolutionFollowing cataract surgery with DEXTENZA 0.4mg insert, patients will receive: Prolensa 0.07% QD X 4 Weeks and stop

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Diagnosed with clinically significant cataract and are planning to undergo non-complicated Clear Cornea Incision Cataract Extraction with Posterior Capsule IntraOcular Lens in one or both eyes
Are willing and able to comply with clinic visits and study related procedures
Are willing and able to sign the informed consent form

Key exclusion criteria (18 listed)

Under the age of 18 at the time of signing the Informed Consent Form
Pregnant or planning to become pregnant during the trial period
Have visual acuity potential of less than 20/30 as recorded by a Retinal Acuity Meter or Potential Acuity Meter glare testing
Have active infectious systemic disease
Have active infectious ocular or extraocular disease

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
Dextenza 0.4Mg Ophthalmic InsertAlso: Dexamethasone 0.4mgDEXTENZA 0.4Mg Ophthalmic Insert is a corticosteroid (to decrease inflammation) intracanalicular insert placed in the punctum, a natural opening in the eye lid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives.	Drug	Arm 2 - Cataract surgery with Dextenza and less frequency of gtt regimen
Prednisolone Acetate 1% Oph SuspPrednisolone Acetate 1% is a corticosteroid (to decrease inflammation) and being used as a topical drop after cataract surgery per Standard Of Care.	Drug	Arm 1 - Cataract surgery gtt regimen per SOC
Prolensa 0.07% Ophthalmic SolutionProlensa 0.07% is a NSAID (to decrease inflammation, swelling and pain) and is being used as a topical drop after cataract surgery per Standard Of Care.	Drug	Arm 1 - Cataract surgery gtt regimen per SOC, Arm 2 - Cataract surgery with Dextenza and less frequency of gtt regimen

Primary outcome

Mean change in anterior chamber inflammation (Cell and Flare) scores
Time frame: Assessed on Days 1,7,30,90
Measured by SUN (Standardization on Uveitis Nomenclature) grading scale: absence of cell to be defined as a grade of 0-0.5 and absence of flare to be defined as a grade of: 0-1. 0-4 score scale, higher scores mean a worse outcome. 0-1 Absent, 1-2 Mild, 2-3 Moderate, 4 Severe.
Mean change in pain score
Time frame: Assessed on Day 1,7, 30 and 90
Measured with the visual analog scale (VAS); between 0 and 100; 0 meaning no pain and 100 meaning worst pain possible, higher scores mean a worse outcome. 0-10 Absent, 11-30 Mild, 31-70 Moderate, 71-100 Severe.

3 secondary outcomes

Visual outcome (Best Corrected Visual Acuity)
Time frame: Assessed on Day 1,7, 30 and 90
Absence of CME (Cystoid Macular Edema)
Time frame: Assessed on Day 90
Mean change in corneal staining
Time frame: Assessed on Day 7, 30 and 90

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
Background: PubMed 14078871ARMALY MF. EFFECT OF CORTICOSTEROIDS ON INTRAOCULAR PRESSURE AND FLUID DYNAMICS. II. THE EFFECT OF DEXAMETHASONE IN THE GLAUCOMATOUS EYE. Arch Ophthalmol. 1963 Oct;70:492-9. doi: 10.1001/archopht.1963.00960050494011. No abstract available.
Background: PubMed 30689622Patel SB, Reddy NK, He YG. TOXIC POSTERIOR SEGMENT SYNDROME AFTER DROPLESS CATARACT SURGERY WITH COMPOUNDED TRIAMCINOLONE-MOXIFLOXACIN. Retina. 2020 Mar;40(3):446-455. doi: 10.1097/IAE.0000000000002450.
Background: PubMed 37643045Freire FS, Lang R, Abalem MF, Johnson MW. RETINAL DEPOSITS OF TRIAMCINOLONE-MOXIFLOXACIN AFTER DROPLESS CATARACT SURGERY. Retin Cases Brief Rep. 2023 Sep 1;17(5):577-580. doi: 10.1097/ICB.0000000000001243.
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.
Background: PubMed 35992569Ibach MJ, Zimprich L, Wallin DD, Olevson C, Puls-Boever K, Thompson V. In Clinic Optometrist Insertion of Dextenza (Dexamethasone Ophthalmic Insert 0.4mg) Prior to Cataract Surgery: The PREPARE Study. Clin Ophthalmol. 2022 Aug 13;16:2609-2615. doi: 10.2147/OPTH.S374405. eCollection 2022.
Background: PubMed 34506241Ibach MJ, Shafer BM, Wallin DD, Puls-Boever KR, Thompson VM, Berdahl JP. The Effectiveness and Safety of Dextenza 0.4 mg for the Treatment of Postoperative Inflammation and Pain in Patients After Photorefractive Keratectomy: The RESTORE Trial. J Refract Surg. 2021 Sep;37(9):590-594. doi: 10.3928/1081597X-20210610-05. Epub 2021 Sep 1.
Background: PubMed 39051020Alsetri H, Fram N, Shiler O. Evaluating a Sustained-Release Dexamethasone Insert as Adjunctive Therapy for Inflammation and Pain Post-Corneal Transplantation. Clin Ophthalmol. 2024 Jul 16;18:2083-2091. doi: 10.2147/OPTH.S466118. eCollection 2024.
Background: PubMed 36532822Fram N, Alsetri H, Shiler O, Paterno PJ, Cabang J. Retrospective Study of a Sustained-Release Intracanalicular Dexamethasone Insert for Treatment of Ocular Inflammation After Cataract and Corneal Surgery. Clin Ophthalmol. 2022 Dec 10;16:4065-4074. doi: 10.2147/OPTH.S386702. eCollection 2022.
Background: PubMed 39089352Shapiro JN, Armenti ST, Levine H, Hood CT, Mian SI. Dexamethasone Intracanalicular Insert versus Standard Topical Steroids for the Prophylaxis of Inflammation after Cataract Surgery. Am J Ophthalmol. 2024 Dec;268:174-180. doi: 10.1016/j.ajo.2024.07.030. Epub 2024 Jul 31.
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 26703279Walters T, Endl M, Elmer TR, Levenson J, Majmudar P, Masket S. Sustained-release dexamethasone for the treatment of ocular inflammation and pain after cataract surgery. J Cataract Refract Surg. 2015 Oct;41(10):2049-59. doi: 10.1016/j.jcrs.2015.11.005.
Background: PubMed 37600148Donnenfeld ED, Hovanesian JA, Malik AG, Wong A. A Randomized, Prospective, Observer-Masked Study Comparing Dropless Treatment Regimen Using Intracanalicular Dexamethasone Insert, Intracameral Ketorolac, and Intracameral Moxifloxacin versus Conventional Topical Therapy to Control Postoperative Pain and Inflammation in Cataract Surgery. Clin Ophthalmol. 2023 Aug 15;17:2349-2356. doi: 10.2147/OPTH.S422502. eCollection 2023.
Dextenza \[package insert\]. Bedford, MA: Ocular Therapeutix, Inc; 2019Link provided by the sponsor.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Nicole R Fram, M.D. principal investigator

Advanced Vision Care

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 18 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: finished, as of the sponsor's last update on 20 Feb 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in anterior chamber inflammation (Cell and Flare) scores (time frame: Assessed on Days 1,7,30,90). The study lists 2 primary outcomes in all. 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 NCT05626478, which also lists 20 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 20 Feb 2026.