A Phase 4 interventional study of Dextenza 0.4Mg Ophthalmic Insert and Prednisolone Acetate 1% Oph Susp in Cataract Diabetic and Macula Edema, sponsored by Baylor Research Institute. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by Baylor Research Institute · Phase 4, Interventional, and Treatment
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.
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.
Baylor Research Institute is the lead sponsor of 219 studies on the registry; 49 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 9 (39%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Standard post-cataract surgery therapy arm; acts as control in each patient.
Drug: Prednisolone Acetate 1% Oph Susp
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.
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.
Optical Coherence Tomography (OCT)
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%.
Time frame: 7 days
Optical Coherence Tomography (OCT)
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%.
Time frame: 14 days
Optical Coherence Tomography (OCT)
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%.
Time frame: 30 days
Macular Edema
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%.
Time frame: 7 days
Macular Edema
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%.
Time frame: 14 days
Macular Edema
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%.
Time frame: 30 days
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Baylor Research Institute