Phase 4 N=80 Randomized Single-blind Prevention

Effect of Intraoperative Dexamethasone on Post-op Dry Eye

Dry Eye Syndromes

Bottom Line

View on ClinicalTrials.gov: NCT04184999 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2021

Primary outcome: Primary: Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively — 311.15; 316.3 mOsmol/L — p=<.01

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: dexamethasone intraocular suspension, 9% (Drug); Prednisolone Acetate 1% Oph Susp (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: SR Cornea Consultants
Primary completion: Dec 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively	311.15; 316.3	<.01 sig

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04184999). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.