PREFERENTIAL Study

November 16, 2021 updated by: Duke University

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)

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

Study Overview

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).

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: DEXTENZA vs prednisolone acetate 1%)
Subjects will randomly receive Dextenza or prednisolone acetate 1% in the first eye after surgery. At the time of the second eye surgery, the other eye will receive the drug that the first eye did not receive. Subjects will receive both drugs during the course of the study and therefore there is only 1 ARM for this study.
The eye will have a sustained release device of Dexamethasone 0.4 mg placed in the inferior nasal lacrimal system.
The eye will be randomized to receive topical treatment with prednisolone acetate 1% on a tapering dose schedule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of patients who stated they preferred dexamethasone insert as measured by patient report
Time Frame: 45 days post second surgery
To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by Modified COMTOL survey.
45 days post second surgery
Percent of patients who stated they preferred topical prednisolone insert as measured by patient report
Time Frame: 45 days post second surgery
To determine patient preference for the dexamethasone insert or topical prednisolone therapy through at Day 45 as measured by Modified COMTOL survey.
45 days post second surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of AE
Time Frame: Up to 3 months
The incidence of adverse events
Up to 3 months
The severity of AE
Time Frame: Up to 3 months
The severity of adverse events
Up to 3 months
Resolution of inflammation
Time Frame: Day 14 post surgery
Resolution of inflammation as defined as either 0 or 0.5 cells or less cells on post-surgical day 14 as measured by SUN scale in an unmasked fashion.
Day 14 post surgery
Resolution of pain
Time Frame: Day 7 post surgery
Resolution of pain as defined by a score of 0 measured by pain scale on post-surgical day 7
Day 7 post surgery
Absence of cell flare at day 14
Time Frame: Day 14 post surgery
Absence of cell flare at day 14
Day 14 post surgery
Mean change in BCVA
Time Frame: Baseline, 3 months
Mean change in BCVA
Baseline, 3 months
Mean change in central retinal thickness as measured by OCT
Time Frame: Baseline, 3 months
Mean change in central retinal thickness as measured by OCT
Baseline, 3 months
Percent of patients who maintained normalized central retinal thickness at 28 days post surgery
Time Frame: 28 days post surgery
Percent of patients who maintained normalized central retinal thickness at 28 days post surgery
28 days post surgery
Percent of patients with rebound inflammation
Time Frame: Up to 3 months
Percent of patients with rebound inflammation
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Leon Herndon, MD, Duke Eye Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2020

Primary Completion (ANTICIPATED)

November 1, 2021

Study Completion (ANTICIPATED)

November 1, 2021

Study Registration Dates

First Submitted

September 21, 2020

First Submitted That Met QC Criteria

September 21, 2020

First Posted (ACTUAL)

September 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 17, 2021

Last Update Submitted That Met QC Criteria

November 16, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cataract Surgery

Clinical Trials on Dextenza 0.4Mg Ophthalmic Insert

3
Subscribe