Anterior Chamber InflammationNCT04975971
A Retrospective Review of DEXTENZA 0.4 mg inseRt Following Corneal Transplant or Cataract Surgery
An observational study of Anterior Chamber Inflammation and Ocular Pain, run by Nicole Fram M.D. at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Chamber Inflammation, Ocular Pain, Corneal Edema
- What is being tested?
- Dextenza 0.4Mg Ophthalmic Insert
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2021to 19 May 2021
- Phase
- Observational
- 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
Study population: 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
Who may be able to join
- Age 18 years and older
- Patients who received DEXTENZA insertion perioperatively.
Who cannot join
- Any patient who did not receive DEXTENZA insertion
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Conditions
- Anterior Chamber Inflammation, Ocular Pain, Corneal Edema, Corneal Defect, Penetrating KeratoPlasty, Nuclear Cataract
- Being tested
- Dextenza 0.4Mg Ophthalmic Insert
- Medical subject headings
- Eye Pain, Corneal 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 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.
| Study group | Role | What they receive |
|---|---|---|
| Dextenza recepient | A Retrospective Review DEXTENZA Intracanalicular Dexamethasone (0.4 mg) Insert Prior to or Following Corneal Transplant or Cataract Surgery Receives: Drug: Dextenza 0.4Mg Ophthalmic Insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Assessed for 3 months after drug insertion
Secondary outcomes (8)
Resolution of pain
Resolution of pain as assessed by aquestionnaire in post-op visits
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Assessed for 3 months after drug insertion
Adverse events
Incidence and severity of adverse events
Measured: Assessed for 3 months after drug insertion
Mean change in IOP
Mean change in IOP over post-op visits
Measured: Assessed for 3 months after drug insertion
Change in BCVA
Change in BCVA over post op visits
Measured: Assessed for 3 months after drug insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start9 Mar 2021
- Primary completion19 May 2021
- Study completion19 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior Chamber InflammationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nicole Fram M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicole Fram M.D., Advanced Vision Care
- Investigators
- Nicole R Fram, M.D., Principal investigator, Advanced Vision Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975971
- Sponsor's protocol ID
- AVC-004
- Status last verified
- Jul 2021
- First submitted
- 2 Jul 2021
- Last updated
- 26 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04975971
- Acronym / sponsor ID
- AVC-004
- Conditions
- Anterior Chamber Inflammation, Ocular Pain, Corneal Edema, Corneal Defect, Penetrating KeratoPlasty, Nuclear Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Nicole Fram M.D.University, hospital or other
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 19 May 2021 (actual)
- Study completion
- 19 May 2021 (actual)
- First posted
- 26 Jul 2021 (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.
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
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dextenza recepient | – | Drug: Dextenza 0.4Mg Ophthalmic InsertA Retrospective Review DEXTENZA Intracanalicular Dexamethasone (0.4 mg) Insert Prior to or Following Corneal Transplant or Cataract Surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (2 listed)
- Age 18 years and older
- Patients who received DEXTENZA insertion perioperatively.
Key exclusion criteria (1 listed)
- Any patient who did not receive DEXTENZA insertion
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 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. | Drug | Dextenza recepient |
Primary outcome
Mean change in pain score
Time frame: 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
Mean change in inflammation (Cell and Flare) scores
Time frame: 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
8 secondary outcomes
Resolution of pain
Time frame: Assessed for 1 months after drug insertion
Resolution of anterior chamber inflammation
Time frame: Assessed for 3 months after drug insertion
Proportion of eyes requiring additional post-operative therapy
Time frame: Assessed for 3 months after drug insertion
Number of patient call-backs regarding post-operative pain
Time frame: Assessed for 3 months after drug insertion
Number of pharmacy call-backs regarding post-operative medication
Time frame: Assessed for 3 months after drug insertion
Adverse events
Time frame: Assessed for 3 months after drug insertion
Mean change in IOP
Time frame: Assessed for 3 months after drug insertion
Change in BCVA
Time frame: Assessed for 3 months after drug insertion
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 26 Jul 2021.
- Results publication: 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.
- Dextenza (dexamethasone insert) Prescribing Information, Ocular Therapeutix,Inc.2019Link provided by the sponsor.
- Efficacy and Safety of Sustained Release Dexamethasone for theTreatment of Ocular Pain and Inflammation after Cataract SurgerLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Anterior Chamber Inflammation
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A Phase 3 Study Evaluating the Safety and Efficacy of TRIESENCE® (Injectable Suspension) for the Treatment of Ocular Inflammation and Pain After Ophthalmic Surgery
Postoperative Ocular Inflammation, Postoperative Ocular Pain
RecruitingObservational study
Analysis of Anterior Chamber Inflammation by Optical Coherence Tomography
Uveitis
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?
An observational study of Anterior Chamber Inflammation and Ocular Pain, run by Nicole Fram M.D. 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 1 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 26 Jul 2021. 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.
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 pain score (time frame: Assessed for 3 months after drug insertion). 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 NCT04975971, which also lists 1 linked publication.
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 26 Jul 2021.