Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery (SUSTAIN)

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    40
  • sponsor
    The New York Eye Surgery Center
Updated on 6 April 2022
antibiotics
hypertension
cataract
prednisolone
dexamethasone
glaucoma
ophthalmic solution
brimonidine tartrate ophthalmic solution
eye surgery
glaucoma surgery
prednisolone acetate 1%
bilateral glaucoma

Summary

In this study, the investigators are comparing dexamethasone ophthalmic insert (DEXTENZA®) to the current standard of care, prednisolone acetate 1% eye drops, in a glaucoma population receiving both cataract and minimally-invasive glaucoma surgery (MIGS). DEXTENZA® and prednisolone acetate 1% drops are both steroids used to control inflammation after eye surgery. DEXTENZA®'s method of delivery differs by offering a sustained release of steroid that does not necessitate postoperative anti-inflammatory eye drops. The investigators hypothesize that DEXTENZA® will be as safe as prednisolone acetate 1% drops and as effective at controlling postoperative inflammation following concomitant cataract-MIGS in a glaucoma population. The investigators also hypothesize that DEXTENZA® will be preferred by patients over prednisolone acetate 1% drops.

Description

Glaucoma and cataract surgery patients face an outsize postoperative burden. In addition to taking frequent anti-inflammatory eye drops, they often continue their glaucoma medications. This can cause patient confusion and nonadherence, potentially leading to poor healing, slower recovery period, and/or cystoid macular edema. DEXTENZA®, as a sustained release anti-inflammatory insert, could help preclude adherence difficulties and increase comfort by reducing eye drop load. However, glaucoma surgeons may hesitate to adopt DEXTENZA® due to concerns regarding safety with respect to elevated intraocular pressure. This prospective study will address those concerns directly, providing timely and high-quality clinical evidence comparing DEXTENZA® to standard-of-care steroid eye drops. For physicians and patients, the results of this study will prove immediately useful for therapeutic decision-making.

Details
Condition Glaucoma, Cataract
Treatment Dexamethasone Ophthalmic Insert, Prednisolone Acetate 1% Oph Susp
Clinical Study IdentifierNCT04200651
SponsorThe New York Eye Surgery Center
Last Modified on6 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Cataract surgery candidate and glaucoma present in at least one eye
Minimally-invasive glaucoma surgery candidate in that same eye. Defined by having ocular hypertension requiring a medication, OR as by having mild, moderate, or severe glaucoma that is sufficiently stable and appropriate for operation

Exclusion Criteria

Maintains regular use (daily or more) of systemic or ocular steroids at time of enrollment
Maintains regular use (daily or more) of systemic or ocular nonsteroidal anti-inflammatory drugs at time of enrollment
Anterior chamber cells present at time of enrollment
Recent febrile illness that precludes or delays participation for 3 months
Pregnancy or lactation
Known allergy to dexamethasone
Current recreational drug use
Known allergy to prednisolone
Preexisting ocular pathology likely to confound the visual acuity or comfort endpoints including but not limited to: severe corneal scarring, ocular surface disease, diabetic retinopathy, or macular edema
Treatment with another investigational drug within the last 20 years
Corneal or retinal procedures (laser or incisional) during the study period and 6 months prior
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