Clinical trial NCT04563559: PREFERENTIAL Study
Official title: 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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Cataract Surgery
Glaucoma Surgery
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Ocular Therapeutix, Inc.
First posted: 2020-09-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: Inclusion Criteria:

* Age 18 years and older
* 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 CDVA of at least 20/200 in both eyes
* 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 IOL combined with a Minimally Invasive Glaucoma Surgery (MIGS) procedure in both eyes

Exclusion Criteria:

* Active or history of chronic or recurrent inflammatory eye disease in either eye
* Ocular pain in either eye
* Proliferative diabetic retinopathy in either eye
* Significant macular pathology detected on macular optical coherence tomography evaluation at the screening visit in either eye
* Laser or incisional ocular surgery during the study period and 6 months prior in either eye
* Systemic concomitant pain medication management with pharmacologic class of oxycodone
* Systemic NSAID use

  o Pre-procedural wash-out period for topical NSAIDS, ocular steroid, cyclosporine of 7 days
* Clinically significant macular edema (CSME)
* History of cystoid macular edema in the study eye

Primary outcomes:
measure: Percent of patients who stated they preferred dexamethasone insert as measured by patient report
timeFrame: 45 days post second surgery
measure: Percent of patients who stated they preferred topical prednisolone insert as measured by patient report
timeFrame: 45 days post second surgery
Secondary outcomes:
measure: The incidence of AE
timeFrame: Up to 3 months
measure: The severity of AE
timeFrame: Up to 3 months
measure: Resolution of inflammation
timeFrame: Day 14 post surgery
measure: Resolution of pain
timeFrame: Day 7 post surgery
measure: Absence of cell flare at day 14
timeFrame: Day 14 post surgery
measure: Mean change in BCVA
timeFrame: Baseline, 3 months
measure: Mean change in central retinal thickness as measured by OCT
timeFrame: Baseline, 3 months
measure: Percent of patients who maintained normalized central retinal thickness at 28 days post surgery
timeFrame: 28 days post surgery
measure: Percent of patients with rebound inflammation
timeFrame: Up to 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Duke Eye Center
name: Leon Herndon, MD
role: PRINCIPAL_INVESTIGATOR
References: