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Dry Eye DiseasePhase 4NCT04530864

Pre-Surgical Ocular Surface Treatment With Intracanalicular Dexamethasone Insert And Effect On Intraocular Lens Measurement Accuracy

A Phase 4 study testing Dextenza 0.4Mg Ophthalmic Insert in people with Dry Eye Disease and Cataract Surgery, run by Prism Vision Group.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This prospective study will use a self controlled design for 35 eyes. Patients scheduled to undergo routine cataract surgery in at least one of their eyes will have their pre-surgical measurements performed, IOL calculated and surgery planned. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dextenza 0.4Mg Ophthalmic Insert
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
No sites listed yet
Study dates
Jan 2021to Jul 2021
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

  • 18 years or older
  • Visually significant cataract
  • Dry eye disease
  • BCVA potential of 20/40 or better

Who cannot join

  • Pregnancy
  • Concurrent use of topical glaucoma medications
  • Corneal scarring
  • History of LASIK or PRK
  • History of rigid gas permeable (RGP) lens wear
  • Macular or retinal pathology requiring intervention
  • Cataract surgery complications

Trial locations and contacts

No sites are listed yet.

Stanley Oliveira, BSN contact

(800) 708-8800

soliveira@prismvisiongroup.com

Veronique Ruppe, PHD contact

VRuppe@prismvisiongroup.com

About this study

Official title: Pre-surgical Ocular Surface Treatment With Intracanalicular Dexamethasone Insert and Effect on Intraocular Lens Measurement Accuracy - The PRECISION Study

This prospective study will use a self controlled design for 35 eyes. Patients scheduled to undergo routine cataract surgery in at least one of their eyes will have their pre-surgical measurements performed, IOL calculated and surgery planned. Then they will receive insertion of an intracanalicular dexamethasone insert into the inferior punctum. At 2 weeks (+/- 2 days) post-insertion, patients will return for an identical set of measurements. The IOL will be calculated and the surgery planned based on post-insert data. The insert will be removed if present (manually or via saline irrigation). This self controlled design allows for greater control of potential confounders tied to participants' systemic and ocular health.

Read the detailed description

Ocular surface optimization is a pre-operative necessity. In cataract surgery patients, an unstable tear film reduces the quality of corneal reflections and therefore can compromise K readings, which in turn can affect the accuracy of IOL calculations and result in suboptimum refractive results. To obtain accurate measurements, patients are routinely pre-treated with a variety of medications and therapies. However, these therapies can take time, which may lead to surgical delays.

Steroids can positively impact the stability of the tear film by inhibiting and preventing ocular surface inflammation. Punctal plugs are also widely used for the treatment of dry eye manifestations, by blocking the tear drainage, increasing tear film and eye moisture. Dextenza is a sustained-release dexamethasone intracanalicular insert recently approved by the FDA for pain and inflammation post ophthalmic surgery. It is placed into the canaliculus via the lower punctum and is designed to release steroid medication for 30 days.

Previous studies have demonstrated that ocular surface disease affects the reliability of IOL calculations, potentially affecting outcomes. The insert of a punctal plug that can deliver a sustained release of dexamethasone to the eye 2 weeks (+/- 2 days) prior to final preoperative measurements may provide adequate therapy, improving the ocular surface status and, therefore, improve the reliability of IOL selection in patients undergoing cataract surgery, in a comparatively short amount of time, without introducing patient compliance barriers.

Pre-surgical measurements, IOL calculations, and surgical plans prior to the insertion of the insert will be compared to measurements, IOL calculations, and surgical plans at 2 weeks following intracanalicular dexamethasone insertion. Surgery will proceed with data from the post-insert measurements. Final refractive outcomes at one month from the second eye surgery will be compared to pre-insert data to determine refractive accuracy.

Being tested
Dextenza 0.4Mg Ophthalmic Insert
Medical subject headings
Dry Eye Syndromes

What participants receive

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

  • Dextenza 0.4Mg Ophthalmic InsertDrug

    All patients will receive pre-surgical ocular surface treatment with intracanalicular sustained release dexamethasone, 0.4 mg

Study groups in NCT04530864
Study groupRoleWhat they receive
DEXTENZA InsertExperimentalThis prospective study will use a self controlled design for 35 eyes. Patients scheduled to undergo routine cataract surgery in at least one of their eyes will have their pre-surgical measurements performed, IOL calculated and surgery planned. Then they will receive insertion of an intracanalicular dexamethasone insert into the inferior punctum. At 2 weeks (+/- 2 days) post-insertion, patients will return for an identical set of measurements. The IOL will be calculated and the surgery planned based on post-insert data. The insert will be removed if present (manually or via saline irrigation). This self controlled design allows for greater control of potential confounders tied to participants' systemic and ocular health.
Receives: Drug: Dextenza 0.4Mg Ophthalmic Insert

What is being measured

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

  1. The change in baseline data (power calculation and astigmatism management) measured by IOL Master 700 and post insert of Dextenza data (power calculation and astigmatism management) measured by IOL Master 700.

    Measured: at 8 weeks (Day 0) and final refractive outcome 1 month post-op visit

Secondary outcomes (3)

  1. The change in inflammatory markers measured by MMP9

    Measured: 6 weeks BEFORE surgery from pre-insert at 8 weeks BEFORE surgery

  2. Change in Tear Break-up Time

    Measured: 6 weeks BEFORE surgery from pre-insert at 8 weeks BEFORE surgery

  3. Change in Standard Patient Evaluation of Eye Dryness Questionnaire (SPEED)

    The Standard Patient Evaluation of Eye Dryness Questionnaire (SPEED) evaluates both the frequency and severity of symptoms. The patient grades the severity of her symptoms on a scale of zero to four with zero being no symptoms and four being intolerable symptoms. The numeric value for each answer is simply added with scores ranging from zero to 28. 0-4 MILD dry eye symptoms, 5-7 MODERATE dry eye symptoms, + SEVERE dry eye symptoms.

    Measured: 6 weeks BEFORE surgery from pre-insert at 8 weeks BEFORE surgery

Timeline

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

  1. First posted28 Aug 2020
  2. Study startJan 2021 (estimated)
  3. Primary completionJan 2021 (estimated)
  4. Study completionJul 2021 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04530864
Sponsor's protocol ID
DEXTENZA OTX
Status last verified
Dec 2020
First submitted
23 Jul 2020
Last updated
11 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Epitropoulos AT, Matossian C, Berdy GJ, Malhotra RP, Potvin R. Effect of tear osmolarity on repeatability of keratometry for cataract surgery planning. J Cataract Refract Surg. 2015 Aug;41(8):1672-7. doi: 10.1016/j.jcrs.2015.01.016.

    PubMed 26432124

  • Kim P, Plugfelder S, Slomovic AR. Top 5 pearls to consider when implanting advanced-technology IOLs in patients with ocular surface disease. Int Ophthalmol Clin. 2012 Spring;52(2):51-8. doi: 10.1097/IIO.0b013e31824b4504. No abstract available.

    PubMed 22395627

  • Goldberg DF. Preoperative evaluation of patients before cataract and refractive surgery. Int Ophthalmol Clin. 2011 Spring;51(2):97-107. doi: 10.1097/IIO.0b013e31820f1f76. No abstract available.

    PubMed 21383583

  • Ale Magar JB. Comparison of the corneal curvatures obtained from three different keratometers. Nepal J Ophthalmol. 2013 Jan-Jun;5(1):9-15. doi: 10.3126/nepjoph.v5i1.7815.

    PubMed 23584640

  • Manning CA, Kloess PM. Comparison of portable automated keratometry and manual keratometry for IOL calculation. J Cataract Refract Surg. 1997 Oct;23(8):1213-6. doi: 10.1016/s0886-3350(97)80318-5.

    PubMed 9368167

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dextenza 0.4Mg Ophthalmic Insert in people with Dry Eye Disease and Cataract Surgery, run by Prism Vision Group.

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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

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

Contact Stanley Oliveira, BSN ((800) 708-8800, soliveira@prismvisiongroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change in baseline data (power calculation and astigmatism management) measured by IOL Master 700 and post insert of Dextenza data (power calculation and astigmatism management) measured by IOL Master 700. (time frame: at 8 weeks (Day 0) and final refractive outcome 1 month post-op visit). 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 NCT04530864, which also lists 5 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 11 Dec 2020.

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