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OpenTrials
Completed

NCT Number: NCT04184999

Effect of Intraoperative Dexamethasone on Post-op Dry Eye

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.

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hauser Ross Surgical Center

Sycamore, Illinois, 60178, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dexamethasone intraocular suspension, 9%

Drug

single dose intracameral corticosteroid

Other names: Dexycu

Prednisolone Acetate 1% Oph Susp

Drug

topical ophthalmic steroid drop

Primary outcomes

  1. Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively

    Time frame: 3 weeks

    Tear Film Osmolarity as measured on Tear Lab system; validated measure of Tear Film Osmolarity Osmolarity was reported in milliosmoles per liter (mOsmol/L)

Sponsors and collaborators

Lead sponsor

SR Cornea Consultants

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 4, 2019
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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