NCT04563559

PREFERENTIAL Study

Patient PReference, Efficacy, and SaFety of an Intracanalicular DExamenthasone InseRt comparEd to Topical PrednisoloNe in PatienTs UndergoIng SequentiAl PhacoemuLsification With Intraocular Lens Surgery OR Combined Phacoemulsification With IOL and a Minimally Invasive Glaucoma Surgery (MIGS)

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by - Modified COMTOL survey.

Detailed description

Eyes from 80 patients will be randomized in a 1:1 ratio to the assigned treatment, dexamethasone insert placed at the time of surgery, or topical prednisolone acetate 1% therapy prescribed on a tapering dose schedule post-operatively. Males and Females 18 years and older with 1)Presence of a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens (IOL), and potential postoperative Snellen pinhole corrected distance visual acuity (CDVA) of at least 20/200 in both eyes and 2) 10 patients with mild-to-moderate primary open angle glaucoma and a visually significant cataract with plans to undergo clear cornea cataract surgery with phacoemulsification and implantation of a posterior chamber Intraocular Len (IOL) combined with a Minimally Invasive Glaucoma Surgery (MIGS) procedure in both eyes. Study visits will consist of eye exam with ocular photos from an Optical Coherence Tomography (OCT).

Conditions

• Cataract Surgery
• Glaucoma Surgery

Interventions

Type	Name	Description
DRUG	Dextenza 0.4Mg Ophthalmic Insert	The eye will have a sustained release device of Dexamethasone 0.4 mg placed in the inferior nasal lacrimal system.
DRUG	Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]	The eye will be randomized to receive topical treatment with prednisolone acetate 1% on a tapering dose schedule

Timeline

• Start date: 2020-11-01
• Primary completion: 2021-11-01
• Completion: 2021-11-01
• First posted: 2020-09-24
• Last updated: 2021-11-17

Regulatory

• FDA-regulated drug study