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

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.

Study Overview

• Status: Unknown
• Conditions: Ocular Surface Disease; Dry Eye Disease; Cataract Surgery
• Intervention / Treatment: Drug: Dextenza 0.4Mg Ophthalmic Insert

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.

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Stanley Oliveira, BSN; Phone Number: (800) 708-8800; Email: soliveira@prismvisiongroup.com
• Study Contact Backup: Name: Veronique Ruppe, PHD; Email: VRuppe@prismvisiongroup.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: Dextenza 0.4Mg Ophthalmic Insert; All patients will receive pre-surgical ocular surface treatment with intracanalicular sustained release dexamethasone, 0.4 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	at 8 weeks (Day 0) and final refractive outcome 1 month post-op visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in inflammatory markers measured by MMP9		6 weeks BEFORE surgery from pre-insert at 8 weeks BEFORE surgery
Change in Tear Break-up Time		6 weeks BEFORE surgery from pre-insert at 8 weeks BEFORE surgery
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.	6 weeks BEFORE surgery from pre-insert at 8 weeks BEFORE surgery

Collaborators and Investigators

• Sponsor: Prism Vision Group
• Collaborators: Ocular Therapeutix, Inc.
• Investigators: Principal Investigator: Cynthia Matossian, MD, Matossian Eye Associates

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: July 23, 2020
• First Submitted That Met QC Criteria: August 25, 2020
• First Posted (Actual): August 28, 2020

Study Record Updates

• Last Update Posted (Actual): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lens Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Cataract; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101
• Other Study ID Numbers: DEXTENZA OTX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes