Pre-Surgical Ocular Surface Treatment With Intracanalicular Dexamethasone Insert And Effect On Intraocular Lens Measurement Accuracy
NCT ID: NCT04530864
Last Updated: 2020-12-11
Study Results
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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UNKNOWN
PHASE4
35 participants
INTERVENTIONAL
2021-01-31
2021-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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DEXTENZA Insert
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.
Dextenza 0.4Mg Ophthalmic Insert
All patients will receive pre-surgical ocular surface treatment with intracanalicular sustained release dexamethasone, 0.4 mg
Interventions
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Dextenza 0.4Mg Ophthalmic Insert
All patients will receive pre-surgical ocular surface treatment with intracanalicular sustained release dexamethasone, 0.4 mg
Eligibility Criteria
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Inclusion Criteria
* Visually significant cataract
* Dry eye disease
* BCVA potential of 20/40 or better
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Ocular Therapeutix, Inc.
INDUSTRY
Prism Vision Group
OTHER
Responsible Party
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Cynthia Matossian
Principal Investigator
Principal Investigators
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Cynthia Matossian, MD
Role: PRINCIPAL_INVESTIGATOR
Matossian Eye Associates
Central Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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DEXTENZA OTX
Identifier Type: -
Identifier Source: org_study_id