In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery

Phase 4

Completed

Conditions: Cataract

Interventions: Drug: Dextenza 0.4Mg Ophthalmic Insert
Drug: Topical prednisolone acetate

Registration Number: NCT05023304

Lead Sponsor: Vance Thompson Vision

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group A Dextenza	Dextenza 0.4Mg Ophthalmic Insert	Randomized to dexamethasone ophthalmic insert 0.4mg placed prior to cataract surgery, on the day of surgery.
Group B Topical Prednisolone	Topical prednisolone acetate	Randomized to topical prednisolone acetate 1% four times per day for one week, three times per day for one week, two times per day for one week, and one time per day for one week starting after 4 hours after surgery.

Primary Outcome Measures

Name	Time	Method
Mean Anterior Chamber Cell/Flare Score	Post-op Day 7	Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 +. The scale used is called the (Standardization of Uveitis Nomenclature) SUN Working Group Grading Scheme. AC cell grading schema. The SUN Working Group defined their two AC grading schemas around these two findings. Importantly, for all grading schemas discussed in this article, an improvement in inflammation is a two-step decrease in grade. A worsening of inflammation occurs with a two-step increase in grade. Grade 0 = 0 cells per high power field or HPF; Grade 0.5+ = 1-5 cells HPF; 1+ = 6-15 HPF; 2+ = 16-25 HPF; 3+ = 26-50 HPF; 4+ \>50. The higher the HPF, the more inflammation that can negatively impact a patient's outcome.
Number of Eyes With No Cell or Flare Measured	post-op Week 4.	Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 +. The scale used is called the (Standardization of Uveitis Nomenclature) SUN Working Group Grading Scheme. AC cell grading schema. The SUN Working Group defined their two AC grading schemas around these two findings. Importantly, for all grading schemas discussed in this article, an improvement in inflammation is a two-step decrease in grade. A worsening of inflammation occurs with a two-step increase in grade. Grade 0 = 0 cells per high power field or HPF; Grade 0.5+ = 1-5 cells HPF; 1+ = 6-15 HPF; 2+ = 16-25 HPF; 3+ = 26-50 HPF; 4+ \>50. The higher the HPF, the more inflammation that can negatively impact a patient's outcome.
Mean Pain Score	Post-op Day 1	Mean pain score measured by Visual Analog Score numerical grading scale 0(minimum)-10(maximum) 0= absence of pain 10 = highest possible pain A higher number indicates a higher pain value which may impact a subject's outcomes.
Patient Tolerability (Defined as Patient Preference)	Post-op Week 4	As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) Questionnaire. The COMTOL questionnaire is designed to assess the tolerability of topical ophthalmic medications. It consists of several elements that help evaluate the frequency, severity, and impact of common side effects: Section 1: Ocular Side Effects; Section 2: Local Side Effects; Section 3: Visual Function; Section 4: Impact on Quality of Life. Likert scale is used to measure each question. 1=Never, 2=Rarely, 3=Sometimes, 4 = Often, 5= Always. A higher score suggests that the medication is less well-tolerated and may be negatively impacting the patient's daily activities and overall well-being.

Secondary Outcome Measures

Name	Time	Method
Physician Ease of Use	Day 0	Physician Ease of Use Survey following dexamethasone intracanalicular placement on Surgical Visit on Scale of 0-10 with 10 being most complex (0= minimum value or not complex and 10= maximum complexity). A higher number indicates a worse outcome.
Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline	postop Week 4	Intraocular Pressure as measured by Goldmann Applanation Tonometer, Total number of Participants with increased IOP \> 10mmHg above baseline. Normal intraocular pressure (IOP) is generally considered to be between 10 and 21 millimeters of mercury (mmHg). However, it's important to note that this is just a general range, and individual values can vary. A higher IOP may negatively impact a subject's outcome.
Number of Participants With Post-operative Cystoid Macular Edema (CME)	post-op Week 4	Cystoid Macular Edema (CME) as measured by optical coherence tomography (OCT); Total number of study participants with post-operative CME.
Eye Drop Burden Reported by Participants	post-op Week 4. Patients were not asked to differentiate between eyes when answering the eye drop burden questionnaire	Eye Drop Burden Questionnaire numerical grading scale 8 questions on scale of 1-5 totaling a maximum score of 40. Likert scale used: 1 Very easy, 2. Easy 3. Neither easy nor difficult 4. Difficult 5. Very difficult Low Burden=8-18 Moderate Burden=19-29 High Burden= 30-40 A higher score is considered a worse outcome for a subject.