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

• Sponsor: Nicole Fram M.D. (Other)
• Overall Status: Completed
• CT.gov ID: NCT04975971
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Actual Duration (Months): 2.3
• Patients Per Site Per Month: 10.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anterior Chamber Inflammation; Ocular Pain; Corneal Edema; Corneal Defect; Penetrating KeratoPlasty; Nuclear Cataract; Cortical Cataract; Cataract Senile	Drug: Dextenza 0.4Mg Ophthalmic Insert

Detailed Description

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

Study Design

• Study Type: Observational
• Actual Enrollment: 25 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: 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
• Actual Study Start Date: Mar 9, 2021
• Actual Primary Completion Date: May 19, 2021
• Actual Study Completion Date: May 19, 2021

Arms and Interventions

Arm	Intervention/Treatment
Dextenza recepient A Retrospective Review DEXTENZA Intracanalicular Dexamethasone (0.4 mg) Insert Prior to or Following Corneal Transplant or Cataract Surgery	Drug: 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.; Other Names: Dexamethasone 0.4mg

Outcome Measures

Primary Outcome Measures

1. Mean change in pain score [Assessed for 3 months after drug insertion]

   As measured with the visual analog scale (VAS); between 0 and 100; 0 meaning no pain and 100 meaning worse pain possible

2. Mean change in inflammation (Cell and Flare) scores [Assessed for 3 months after drug insertion]

   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

Secondary Outcome Measures

1. Resolution of pain [Assessed for 1 months after drug insertion]

   Resolution of pain as assessed by aquestionnaire in post-op visits

2. Resolution of anterior chamber inflammation [Assessed for 3 months after drug insertion]

   Resolution of anterior chamber inflammation as measured by SUN grading at the slitlamp in post-op visits

3. Proportion of eyes requiring additional post-operative therapy [Assessed for 3 months after drug insertion]

   Proportion of eyes requiring additional post-operative therapy for pain and inflammation

4. Number of patient call-backs regarding post-operative pain [Assessed for 3 months after drug insertion]

   Number of patient call-backs regarding post-operative pain and medication management

5. Number of pharmacy call-backs regarding post-operative medication [Assessed for 3 months after drug insertion]

   Number of pharmacy call-backs regarding post-operative medication management

6. Adverse events [Assessed for 3 months after drug insertion]

   Incidence and severity of adverse events

7. Mean change in IOP [Assessed for 3 months after drug insertion]

   Mean change in IOP over post-op visits

8. Change in BCVA [Assessed for 3 months after drug insertion]

   Change in BCVA over post op visits

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18 years and older

• Patients who received DEXTENZA insertion perioperatively.

Exclusion Criteria:

• Any patient who did not receive DEXTENZA insertion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Advanced Vision Care	Los Angeles	California	United States	90067

Sponsors and Collaborators

• Nicole Fram M.D.

Investigators

• Principal Investigator: Nicole R Fram, M.D., Advanced Vision Care

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Dextenza (dexamethasone insert) Prescribing Information, Ocular Therapeutix,Inc.2019
• Treatment of Post-operative Inflammation following Cataract Surgery - A Review Published Online: May 3rd 2012 European Ophthalmic Review, 2012;6(2):98-103 DOI: http://doi.org/10.17925/EOR.2012.06.02.98
• Recovery after cataract surgery
• Efficacy and Safety of Sustained Release Dexamethasone for theTreatment of Ocular Pain and Inflammation after Cataract Surger

Publications

None provided.

• Responsible Party: Nicole Fram M.D., Principal Investigator, Advanced Vision Care
• ClinicalTrials.gov Identifier: NCT04975971
• Other Study ID Numbers: AVC-004
• First Posted: Jul 26, 2021
• Last Update Posted: Jul 26, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cataract; Corneal Edema; Inflammation; Dexamethasone

Study Results

No Results Posted as of Jul 26, 2021