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

NCT04530864 | Unknown Phase 4 FDA Drug

• 1 other identifier: DEXTENZA OTX
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Dry Eye Disease; Cataract Surgery; Ocular Surface Disease

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (3)

• 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)

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

Study Arms (1)

DEXTENZA Insert

EXPERIMENTAL

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

Interventions

Dextenza 0.4Mg Ophthalmic Insert DRUG

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

DEXTENZA Insert

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prism Vision Group: lead
• Ocular Therapeutix, Inc.: collaborator

Related Publications (5)

• 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.

  PMID: 26432124 BACKGROUND

• 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.

  PMID: 22395627 BACKGROUND

• 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.

  PMID: 21383583 BACKGROUND

• 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.

  PMID: 23584640 BACKGROUND

• 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.

  PMID: 9368167 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Calcium Dobesilate

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Cynthia Matossian, MD

  Matossian Eye Associates

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stanley Oliveira, BSN

CONTACT

(800) 708-8800; soliveira@prismvisiongroup.com

Veronique Ruppe, PHD

CONTACT

VRuppe@prismvisiongroup.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: August 28, 2020
• Study Start: January 1, 2021
• Primary Completion: January 1, 2021
• Study Completion: July 1, 2021
• Last Updated: December 11, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share