"A Prospective Study of the Efficacy of Intracameral Dexamethasone (Dexycu™) Compared to Standard of Care Treatment for Post-Cataract Surgical Pain and Anterior Chamber Inflammation"

NCT ID: NCT04781335

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-20
• Study Completion Date: 2022-12-22

Brief Summary

Cataract surgery is the most common surgical procedure performed on humans today. The postoperative regimen includes a combination of steroids, NSAIDs (non-steroidal anti-inflammatory drugs) and antibiotics. Those are used to decrease the possibility of infection, inflammation that may lead to corneal and macular edema and pain management. There are several FDA approved agents either for topical use as single drug delivery or combination solutions for topical use as well; furthermore, there are slow release vehicles that may be placed at the time of surgery or postoperatively (at the lower punctum). The latter provides a less intense and demanding drop schedule and may improve patient compliance.

Detailed Description

The current study will assess post cataract the efficacy and safety of two different FDA approved regimens, which include the standard of care (topical steroids, NSAIDs and antibiotics) or Intracameral Dexamethasone (Dexycu™) along with topical NSAIDs and antibiotics.

The hypothesis of the current study is that topical steroids or intracamerally injected steroids as slow release vehicles, demonstrate the same efficacy of controlling post cataract pain and inflammation. We will assess one objective outcome measure, anterior chamber inflammation. This will provide a direct index of the efficacy of the steroidal agents used. Furthermore, a subjective outcome measure, ocular pain, will also be assessed. In cases where a patient in either of the two groups has sever inflammation, rescue medications will be applied, increasing the dosage of topical steroidal agents and the patient will be followed closely until resolved.

The study will include 50 consecutive patients, men and women ages 40 to 90 years old, with visually significant cataract that received bilateral cataract surgery using either the manual technique or femtosecond assisted cataract surgery. Bilateral surgery is common practice and is not performed on the same day. There is a one week time interval between the eyes receiving cataract extraction. The patients that we will enroll in the suggested study will require and will receive bilateral cataract surgery with one week time interval between the two eyes. There are no restrictions on racial or ethnic origin. Employees of The Eye Institute of West Florida will not be enrolled into this study.

Conditions

Cataract

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dexycu

Group Type: ACTIVE_COMPARATOR

Dexycu

Intervention Type: DRUG

This is a contra-lateral randomized study, meaning that in clinic after a patient is identified as a candidate we will "flip a coin" for selection of the eye that is going to receive the Dexycu™ implant (the implant will be placed intracapsularly at the optic haptic junction of the IOL). The patients will receive the SAME topical regimen (Eye with Dexycu™: no steroid, Eye without Dexycu™: steroid will be used). The Dexycu™, topical NSAID, and antibiotic regimen will be provided to all patients in the study, at no cost, in order to avoid difficulties with compliance, insurance, and follow up.

Standard Care Post operative drops

Group Type: ACTIVE_COMPARATOR

Standard of Care post operative eye drops (steroid, antibiotic, NSAID)

Intervention Type: DRUG

This is a contra-lateral randomized study, meaning that in clinic after a patient is identified as a candidate we will "flip a coin" for selection of the eye that is going to receive the Dexycu™ implant (the implant will be placed intracapsularly at the optic haptic junction of the IOL). The patients will receive the SAME topical regimen (Eye with Dexycu™: no steroid, Eye without Dexycu™: steroid will be used). The Dexycu™, topical NSAID, and antibiotic regimen will be provided to all patients in the study, at no cost, in order to avoid difficulties with compliance, insurance, and follow up.

Interventions

Dexycu

This is a contra-lateral randomized study, meaning that in clinic after a patient is identified as a candidate we will "flip a coin" for selection of the eye that is going to receive the Dexycu™ implant (the implant will be placed intracapsularly at the optic haptic junction of the IOL). The patients will receive the SAME topical regimen (Eye with Dexycu™: no steroid, Eye without Dexycu™: steroid will be used). The Dexycu™, topical NSAID, and antibiotic regimen will be provided to all patients in the study, at no cost, in order to avoid difficulties with compliance, insurance, and follow up.

Intervention Type: DRUG

Standard of Care post operative eye drops (steroid, antibiotic, NSAID)

This is a contra-lateral randomized study, meaning that in clinic after a patient is identified as a candidate we will "flip a coin" for selection of the eye that is going to receive the Dexycu™ implant (the implant will be placed intracapsularly at the optic haptic junction of the IOL). The patients will receive the SAME topical regimen (Eye with Dexycu™: no steroid, Eye without Dexycu™: steroid will be used). The Dexycu™, topical NSAID, and antibiotic regimen will be provided to all patients in the study, at no cost, in order to avoid difficulties with compliance, insurance, and follow up.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• • Patients age 40 to 90 years old, with visually significant cataract that received bilateral cataract surgery using either the manual technique or femtosecond assisted cataract surgery

Exclusion Criteria

• • Patients with history of diabetes mellitus and other systemic conditions that may promote inflammation

• patients with previous ocular disease history
• patients with history of ocular surgery
• patients using prescription eye medications topically
• vulnerable subjects or subjects with diminished capacity requiring a POA (Power of Attorney)
• patients with allergies to steroids, NSAID's, or besifloxacin (standard antibiotic)
• women who are pregnant or lactating

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

EyePoint Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

The Eye Institute of West Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert J Weinstock, MD

Role: PRINCIPAL_INVESTIGATOR

The Eye Institute of West Florida

Locations

The Eye Institute of West Florida

Largo, Florida, United States

Countries

United States

Other Identifiers

EIWF-EP001

Identifier Type: -

Identifier Source: org_study_id