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NCT04184999 Clinical Trial

Effect of Intraoperative Dexamethasone on Post-op Dry Eye

Dry Eye Syndromes Clinical Trial

Official title:
Evaluation of Intraoperative Use of Dexycu on the Signs and Symptoms of Dry Eye

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04184999
Other study ID # SRCC10
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 10, 2019
Est. completion date December 1, 2019

Study information
Verified date November 2023
Source SR Cornea Consultants
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare the signs and symptoms of dry eye after cataract surgery between subjects randomized to receive intraoperative dexamethasone in addition to the use of a standard topical post-op treatment regimen.

Description:

Forty patients requiring cataract surgery will be randomized to treatment of post-operative inflammation with a single intraoperative dexamethasone injection plus a standard course of topical ophthalmic corticosteroid drops or the standard treatment alone. Dry eye testing will be administered at baseline, 1 week and 3 weeks following surgery.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date December 1, 2019
Est. primary completion date December 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - undergoing bilateral cataract surgery Exclusion Criteria: - central corneal staining with fluorescein and/or a tear film osmolarity of greater than 340 in either eye

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• dexamethasone intraocular suspension, 9%
single dose intracameral corticosteroid
• Prednisolone Acetate 1% Oph Susp
topical ophthalmic steroid drop

Locations
Country Name City State
United States Hauser Ross Surgical Center Sycamore Illinois

Sponsors (1)
Lead Sponsor Collaborator
SR Cornea Consultants

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively Tear Film Osmolarity as measured on Tear Lab system; validated measure of Tear Film Osmolarity Osmolarity was reported in milliosmoles per liter (mOsmol/L) 3 weeks
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