Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes

Macula Edema Clinical Trial

Official title:

Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04977427
• Other study ID #: iRIS RB Number 021-167
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 2021
• Est. completion date: March 2022

Study information

• Verified date: July 2021
• Source: Baylor Research Institute
• Contact: Jacob Fleenor, MD
• Phone: 4237547507
• Email: Jacob.Fleenor[@]BSWHealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Cataract Diabetic
• Macula Edema

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular Inflammation	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%.	7 days
Primary	Intraocular Inflammation	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%.	14 days
Primary	Intraocular Inflammation	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%.	30 days
Secondary	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%.	7 days
Secondary	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%.	14 days
Secondary	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%.	30 days