A Retrospective Review of DEXTENZA 0.4 mg inseRt Following Corneal Transplant or Cataract Surgery

NCT ID: NCT04975971

Last Updated: 2021-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-09

Study Completion Date

2021-05-19

Brief Summary

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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

Detailed Description

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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

Conditions

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Anterior Chamber Inflammation Ocular Pain Corneal Edema Corneal Defect Penetrating KeratoPlasty Nuclear Cataract Cortical Cataract Cataract Senile

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Dextenza recepient

A Retrospective Review DEXTENZA Intracanalicular Dexamethasone (0.4 mg) Insert Prior to or Following Corneal Transplant or Cataract Surgery

Dextenza 0.4Mg Ophthalmic Insert

Intervention Type 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.

Interventions

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Dextenza 0.4Mg Ophthalmic Insert

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.

Intervention Type DRUG

Other Intervention Names

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Dexamethasone 0.4mg

Eligibility Criteria

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Inclusion Criteria

* Age 18 years and older
* Patients who received DEXTENZA insertion perioperatively.

Exclusion Criteria

* Any patient who did not receive DEXTENZA insertion
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nicole Fram M.D.

OTHER

Sponsor Role lead

Responsible Party

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Nicole Fram M.D.

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nicole R Fram, M.D.

Role: PRINCIPAL_INVESTIGATOR

Advanced Vision Care

Locations

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Advanced Vision Care

Los Angeles, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 30367938 (View on PubMed)

Related Links

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http://www.dextenza.com/wp-content/uploads/2019/06/NDA-208742-S001-Dextenza-labeling-19Jun19.pdf

Dextenza (dexamethasone insert) Prescribing Information, Ocular Therapeutix,Inc.2019

Other Identifiers

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AVC-004

Identifier Type: -

Identifier Source: org_study_id

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