Effect of Intraoperative Dexamethasone on Post-op Dry Eye

Phase 4

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: dexamethasone intraocular suspension, 9%; Drug: Prednisolone Acetate 1% Oph Susp

• Registration Number: NCT04184999
• Lead Sponsor: SR Cornea Consultants

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-08-10
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Study First Submitted: 2019-12-01
• Study First Submitted QC: 2019-12-01
• Study First Posted: 2019-12-04
• Results First Submitted: 2020-11-15
• Results First Submitted QC: 2021-01-09
• Results First Posted: 2021-01-29
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intracameral dexamethasone 9% + postoperative topical prednisolone acetate	dexamethasone intraocular suspension, 9%	dexamethasone intraocular suspension, 9% injected intracamerally at the time of cataract surgery + topical ophthalmic prednisolone acetate for 3 weeks post-operatively
Intracameral dexamethasone 9% + postoperative topical prednisolone acetate	Prednisolone Acetate 1% Oph Susp	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	Prednisolone Acetate 1% Oph Susp	topical ophthalmic prednisolone acetate for 3 weeks post-operatively

Primary Outcome Measures

Name	Time	Method
Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively	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)

Trial Locations

Locations (1)

Hauser Ross Surgical Center; 🇺🇸 Sycamore, Illinois, United States