In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery

Cataract Clinical Trial

— Prepare  

Official title:

In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05023304
• Other study ID #: The Prepare Study
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 23, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: August 2021
• Source: Vance Thompson Vision
• Contact: Keeley Puls-Boever
• Phone: 605-361-3937
• Email: keeley.puls[@]vancethompsonvision.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 1, 2022
• Est. primary completion date: July 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• Dextenza 0.4Mg Ophthalmic Insert
The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.
• Topical Prednisolone
Standard of care topical drop treatment

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Mitchel Ibach	Ocular Therapeutix, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean anterior chamber cell/flare score	Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 + (SUN Working Group Grading Scheme)	post-op Day 1
Primary	Mean anterior chamber cell/flare score	Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 + (SUN Working Group Grading Scheme)	post-op Day 7
Primary	Mean anterior chamber cell/flare score	Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 + (SUN Working Group Grading Scheme)	post-op Week 4.
Primary	Mean pain score	Mean pain score measured by Visual Analog Score numerical grading scale 0-10	post-op Day 1
Primary	Mean pain score	Mean pain score measured by Visual Analog Score numerical grading scale 0-10	post-op Day 7
Primary	Mean pain score	Mean pain score measured by Visual Analog Score numerical grading scale 0-10	post-op Week 4
Primary	Patient preference	As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) Questionnaire	post-op Week 4
Secondary	Incidence of increased intraocular pressure (IOP) >10mmHg above baseline	Incidence of increased intraocular pressure (IOP) >10mmHg above baseline as measured by Goldmann Applanation Tonometer	postop Day 1
Secondary	Incidence of increased intraocular pressure (IOP) >10mmHg above baseline	Incidence of increased intraocular pressure (IOP) >10mmHg above baseline as measured by Goldmann Applanation Tonometer	postop Day 7
Secondary	Incidence of increased intraocular pressure (IOP) >10mmHg above baseline	Incidence of increased intraocular pressure (IOP) >10mmHg above baseline as measured by Goldmann Applanation Tonometer	postop Week 4
Secondary	Incidence of Cystoid Macular Edema (CME)	Incidence of Cystoid Macular Edema (CME) as measured by optical coherence tomography (OCT)	post-op Week 4
Secondary	Physician Ease of Use	Physician Ease of Use Survey following dexamethasone intracanalicular placement on Surgical Visit	Day 0
Secondary	Eye Drop Burden	Eye Drop Burden Questionnaire numerical grading scale of 1-5	post-op Day 7
Secondary	Eye Drop Burden	Eye Drop Burden Questionnaire numerical grading scale of 1-5	post-op Week 4