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A Retrospective Review of Pain and Inflammation Resolution Outcomes in Patients Who Received DEXTENZA Intracanalicular Dexamethasone (0.4 mg) Insert Prior to or Following Corneal transplant or Cataract surgery
A Retrospective Review of Pain and Inflammation Resolution Outcomes in Patients Who Received DEXTENZA Intracanalicular Dexamethasone (0.4 mg) Insert, placed within the lower or upper eye lid canaliculus in conjunction with topical steroid Prior to or Following Corneal transplant or Cataract surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dextenza recepient | A Retrospective Review DEXTENZA Intracanalicular Dexamethasone (0.4 mg) Insert Prior to or Following Corneal Transplant or Cataract Surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dextenza 0.4Mg Ophthalmic Insert | Drug | DEXTENZA is a corticosteroid 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in pain score | As measured with the visual analog scale (VAS); between 0 and 100; 0 meaning no pain and 100 meaning worse pain possible | Assessed for 3 months after drug insertion |
| Mean change in inflammation (Cell and Flare) scores | As 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 | Assessed for 3 months after drug insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of pain | Resolution of pain as assessed by aquestionnaire in post-op visits | Assessed for 1 months after drug insertion |
| Resolution of anterior chamber inflammation | Resolution of anterior chamber inflammation as measured by SUN grading at the slitlamp in post-op visits |
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Inclusion Criteria:
Exclusion Criteria:
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The study will evaluate n=25 (25 eyes) who underwent corneal transplant or cataract surgery and received DEXTENZA insertion prior to or following surgery as documented in E.H.R
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| Name | Affiliation | Role |
|---|---|---|
| Nicole R Fram, M.D. | Advanced Vision Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Vision Care | Los Angeles | California | 90067 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30367938 | Result | 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. |
| Label | URL |
|---|---|
| Dextenza (dexamethasone insert) Prescribing Information, Ocular Therapeutix,Inc.2019 | View source |
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|
| Assessed for 3 months after drug insertion |
| Proportion of eyes requiring additional post-operative therapy | Proportion of eyes requiring additional post-operative therapy for pain and inflammation | Assessed for 3 months after drug insertion |
| Number of patient call-backs regarding post-operative pain | Number of patient call-backs regarding post-operative pain and medication management | Assessed for 3 months after drug insertion |
| Number of pharmacy call-backs regarding post-operative medication | Number of pharmacy call-backs regarding post-operative medication management | Assessed for 3 months after drug insertion |
| Adverse events | Incidence and severity of adverse events | Assessed for 3 months after drug insertion |
| Mean change in IOP | Mean change in IOP over post-op visits | Assessed for 3 months after drug insertion |
| Change in BCVA | Change in BCVA over post op visits | Assessed for 3 months after drug insertion |
| Efficacy and Safety of Sustained Release Dexamethasone for theTreatment of Ocular Pain and Inflammation after Cataract Surger | View source |
| ID | Term |
|---|---|
| D058447 | Eye Pain |
| D015715 | Corneal Edema |
| ID | Term |
|---|---|
| D005132 | Eye Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D003316 | Corneal Diseases |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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