Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes

Sponsor
Baylor Research Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04977427
Collaborator
(none)
200
Enrollment
2
Arms
8
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study aims to compare the effectiveness of Dextenza vs standard of care prednisolone taper after cataract surgery in diabetic patients with regards to controlling post-op inflammation at post-op days 7, 14, and 30.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Dextenza 0.4Mg Ophthalmic Insert
  • Drug: Prednisolone Acetate 1% Oph Susp
Phase 4

Detailed Description

The inflammation after cataract surgery is controlled at the investigators' institution by a taper of prednisolone acetate 1%, which consists of four drops daily for one week, followed by three drops daily for one week, then two drops daily for one week, then one drop daily for one week. Due to the frequency of drops needed after cataract surgery, compliance with the post-op regimen often wavers. This study aims to evaluate the efficacy of Dextenza, which has been shown to be better than placebo after cataract surgery (1), against prednisolone acetate taper. If shown to be as effective without compromising safety, it could be a very convenient alternative to prednisolone acetate taper. Furthermore, if Dextenza is shown to be as effective as prednisolone taper in diabetic patients, it could be logically generalized that it would be effective in patients without diabetes as well, as patients without diabetes (and with no confounding risk factors, such as a history of uveitis) are less prone to developing post-op macular edema. Risks are minimal for this FDA approved treatment and include iridocyclitis (10%); intraocular pressure increased (6%); visual acuity reduced (2%); cystoid macular edema (1%); corneal edema (1%); eye pain (1%) and conjunctival hyperemia (1%). These risks are comparable to prednisolone acetate.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized Fellow-Eye study design, in which one randomized eye in each patient undergoing bilateral cataract surgery receives standard prednisolone therapy, the other eye receiving the investigational Dextenza treatment.Randomized Fellow-Eye study design, in which one randomized eye in each patient undergoing bilateral cataract surgery receives standard prednisolone therapy, the other eye receiving the investigational Dextenza treatment.
Masking:
Single (Outcomes Assessor)
Masking Description:
Unable to fully mask to investigator in order to maintain safety (must assess the investigational Dextenza insert and its position in the lower punctum at each office visit).
Primary Purpose:
Treatment
Official Title:
Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Prednisolone Arm

Standard post-cataract surgery therapy arm; acts as control in each patient.

Drug: Prednisolone Acetate 1% Oph Susp
Standard Prednisolone taper following cataract surgery, QID for one week, followed by TID for one week, BID for one week, and QDaily for one week, then stop.

Active Comparator: Dextenza Arm

Investigational arm to compare the effectiveness of the Dextenza insert to standard therapy.

Drug: Dextenza 0.4Mg Ophthalmic Insert
Dexamethasone inserted into lower punctum at the end of cataract surgery in order to control inflammation in the eye for the following 30 days after surgery.

Outcome Measures

Primary Outcome Measures

  1. Intraocular Inflammation [7 days]

    The investigators will assess the effect of 0.4mg dexamethasone intracanalicular insert on the presence or absence of inflammation in the eye following cataract surgery when compared to prednisolone acetate 1%.

  2. Intraocular Inflammation [14 days]

    The investigators will assess the effect of 0.4mg dexamethasone intracanalicular insert on the presence or absence of inflammation in the eye following cataract surgery when compared to prednisolone acetate 1%.

  3. Intraocular Inflammation [30 days]

    The investigators will assess the effect of 0.4mg dexamethasone intracanalicular insert on the presence or absence of inflammation in the eye following cataract surgery when compared to prednisolone acetate 1%.

Secondary Outcome Measures

  1. Macular Edema [7 days]

    The investigators will assess the effect of 0.4mg dexamethasone intracanalicular insert on the presence or absence of macular edema in the eye on OCT imaging following cataract surgery when compared to prednisolone acetate 1%.

  2. Macular Edema [14 days]

    The investigators will assess the effect of 0.4mg dexamethasone intracanalicular insert on the presence or absence of macular edema in the eye on OCT imaging following cataract surgery when compared to prednisolone acetate 1%.

  3. Macular Edema [30 days]

    The investigators will assess the effect of 0.4mg dexamethasone intracanalicular insert on the presence or absence of macular edema in the eye on OCT imaging following cataract surgery when compared to prednisolone acetate 1%.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patients with diagnosed diabetes

  • Patients must be undergoing cataract surgery in each eye

  • Patients must have no worse than moderate nonproliferative diabetic retinopathy

Exclusion Criteria:
  • Patients must not have any history of documented macular edema on OCT

  • Patients must not have any macular edema on pre-op OCT

  • Patients must not have any history of uveitis

  • Patients must not have severe nonproliferative or proliferative diabetic retinopathy

  • Patients with operative complications will be excluded from this study

  • Patients with any active corneal disease, infectious or rheumatologic, will be excluded

  • Patients must not be pregnant

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Baylor Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jacob Fleenor, Resident Physician, Principal Investigator, Baylor Research Institute
ClinicalTrials.gov Identifier:
NCT04977427
Other Study ID Numbers:
  • iRIS RB Number 021-167
First Posted:
Jul 27, 2021
Last Update Posted:
Jul 27, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jacob Fleenor, Resident Physician, Principal Investigator, Baylor Research Institute
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2021