Title

Effect of Intraoperative Dexamethasone on Post-op Dry Eye
Evaluation of Intraoperative Use of Dexycu on the Signs and Symptoms of Dry Eye
  • Phase

    Phase 4
  • Study Type

    Interventional
  • Study Participants

    40
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.
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.
Study Started
Aug 10
2019
Primary Completion
Dec 01
2019
Study Completion
Dec 01
2019
Results Posted
Jan 29
2021
Last Update
Nov 22
2023

Drug dexamethasone intraocular suspension, 9%

single dose intracameral corticosteroid

  • Other names: Dexycu

Drug Prednisolone Acetate 1% Oph Susp

topical ophthalmic steroid drop

Intracameral dexamethasone 9% + postoperative topical prednisolone acetate Experimental

dexamethasone intraocular suspension, 9% injected intracamerally at the time of cataract surgery + topical ophthalmic prednisolone acetate for 3 weeks post-operatively

postoperative topical prednisolone acetate Active Comparator

topical ophthalmic prednisolone acetate for 3 weeks post-operatively

Criteria

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

Summary

Intracameral Dexamethasone + Postoperative Prednisolone Acetate

Postoperative Prednisolone Acetate Regimen

All Events

Event Type Organ System Event Term

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)

Intracameral Dexamethasone

311.15
mOsmol/L (Mean)
95% Confidence Interval: 284.0 to 333.0

Intracameral Dexamethasone

311.15
mOsmol/L (Mean)
95% Confidence Interval: 284.0 to 333.0

Postoperative Prednisolone Acetate

316.3
mOsmol/L (Mean)
95% Confidence Interval: 286.0 to 335.0

Postoperative Prednisolone Acetate

316.3
mOsmol/L (Mean)
95% Confidence Interval: 286.0 to 335.0

Total

40
Participants

Total

80
eyes

Age, Continuous

67.49
years (Mean)
Standard Deviation: 10.42

Preoperative Tear Film Osmolarity

307.625
mOsmo/L (Mean)
Full Range: 292.0 to 322.0

Race and Ethnicity Not Collected

0
Participants

Age, Categorical

Region of Enrollment

Sex: Female, Male

Overall Study

Intracameral Dexamethasone + Postoperative Topical Prednisolone

Postoperative Topical Prednisolone