Phase 4
N=60
In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT05023304 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Mean Anterior Chamber Cell/Flare Score — 1.06; 1.15 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dextenza 0.4Mg Ophthalmic Insert (Drug); Topical prednisolone acetate (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vance Thompson Vision
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Anterior Chamber Cell/Flare Score |
0.25; 0.22 | — |
| PRIMARY Mean Anterior Chamber Cell/Flare Score |
0.25; 0.22 | — |
| PRIMARY Number of Eyes With No Cell or Flare Measured |
30; 28 | — |
| PRIMARY Mean Pain Score |
23; 23; 2; 2; 2; 3 | — |
| PRIMARY Patient Tolerability (Defined as Patient Preference) |
29; 0; 1 | — |
| SECONDARY Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline |
0; 0 | — |
| SECONDARY Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline |
0; 0 | — |
| SECONDARY Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline |
0; 0 | — |
| SECONDARY Number of Participants With Post-operative Cystoid Macular Edema (CME) |
0; 0 | — |
| SECONDARY Physician Ease of Use |
3.9 | — |
| SECONDARY Eye Drop Burden Reported by Participants |
28; 2; 0 | — |
| SECONDARY Eye Drop Burden Reported by Participants |
28; 2; 0 | — |
Summary
To evaluate the clinical outcomes with optometrist pre-surgical insertion of DEXTENZA in the clinical office setting in patients undergoing same-day cataract surgery compared to standard of care steroid therapy.
Eligibility Criteria
Inclusion Criteria
- Patients 18 years of age or older, undergoing routine, uncomplicated, sequential bilateral cataract surgery.
- Willing and able to comply with clinic visits and study related procedures
- Willing and able to sign the informed consent form
Exclusion Criteria
- Patients under the age of 18.
- Patients who are pregnant (must be ruled out in women of childbearing age with pregnancy test).
- Active infectious ocular or systemic disease.
- Patients with active infectious ocular or extraocular disease.
- Patients actively treated with local or systemic immunosuppression including systemic corticosteroids.
- Patients with known hypersensitivity to Dexamethasone.
- Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator.
- Patients with proliferative diabetic retinopathy or uncontrolled diabetes as deemed by an A1C > 10.0.
- Patients with a history of ocular inflammation or macular edema.
- Patients with a pre-existing epiretinal membrane (ERM)
- Patients with allergy or inability to receive intracameral antibiotic.
- Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day The PREPARE Study (V1) February, 2021 Page 27 CONFIDENTIAL
- Patients with a corticosteroid implant (i.e. Ozurdex).
Data sourced from ClinicalTrials.gov (NCT05023304). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.