A Study for Post op Inflammation After Cataract Surgery

NCT ID: NCT05665270

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2023-12-15

Brief Summary

This is a randomized, controlled study to assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert when utilized in conjunction with topical steroids as part of an extended taper steroid regimen following cataract surgery in patients with a history of epiretinal membrane, diabetic retinopathy, or non-exudative macular degeneration.

Detailed Description

There will be approximately 40 eyes with two groups:

Group 1 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate drops QID x 1 week, then Dextenza will be inserted at the one-week postoperative evaluation (Day 8).

Group 2 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate for five weeks with dosing schedule: QID x 2 weeks, TID x 1 week, BID x 1 week, QD x 1 week.

Both groups will receive topical Prolensa Qa.m. x 5 weeks and Moxifloxacin TID x 1 week, per investigators preferential treatment regimen.

Each subject's participation is expected to last for approximately 5 weeks and subjects will be required to complete six scheduled visits over the course of the study period: Baseline (Screening Visit Day -1), Operative Visit (Day 0), Day 1, Day 8 (insertion day), Day 14, and Day 37.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dextenza

Group 1 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate drops QID x 1 week, then Dextenza will be inserted at the one-week postoperative evaluation (Day 8).

Group Type: EXPERIMENTAL

Dextenza 0.4Mg Ophthalmic Insert

Intervention Type: DRUG

Group 1 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate drops QID x 1 week, then Dextenza will be inserted at the one-week postoperative evaluation (Day 8). Both groups will receive topical Prolensa Qa.m. x 5 weeks and Moxifloxacin TID x 1 week, per investigators preferential treatment regimen.

Prednisolone Acetate

Group 2 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate for five weeks with dosing schedule: QID x 2 weeks, TID x 1 week, BID x 1 week, QD x 1 week.

Group Type: ACTIVE_COMPARATOR

Prednisolone Acetate 1%

Intervention Type: DRUG

Group 2 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate for five weeks with dosing schedule: QID x 2 weeks, TID x 1 week, BID x 1 week, QD x 1 week.

Both groups will receive topical Prolensa Qa.m. x 5 weeks and Moxifloxacin TID x 1 week, per investigators preferential treatment regimen.

Interventions

Dextenza 0.4Mg Ophthalmic Insert

Group 1 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate drops QID x 1 week, then Dextenza will be inserted at the one-week postoperative evaluation (Day 8). Both groups will receive topical Prolensa Qa.m. x 5 weeks and Moxifloxacin TID x 1 week, per investigators preferential treatment regimen.

Intervention Type: DRUG

Prednisolone Acetate 1%

Group 2 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate for five weeks with dosing schedule: QID x 2 weeks, TID x 1 week, BID x 1 week, QD x 1 week.

Both groups will receive topical Prolensa Qa.m. x 5 weeks and Moxifloxacin TID x 1 week, per investigators preferential treatment regimen.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Subjects will be eligible for study participation if they:

1. Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes and have a history of epiretinal membrane, diabetic retinopathy, or non-exudative macular degeneration.

2. Are willing and able to comply with clinic visits and study related procedures

3. Are willing and able to sign the informed consent form

4. Patients age 18yo+

Exclusion Criteria

Subjects are not eligible for study participation if they:

1. Have active infectious systemic disease

2. Have active infectious ocular or extraocular disease

3. Have an obstructed nasolacrimal duct in the study eye(s) (dacryocystitis)

4. Have known hypersensitivity to dexamethasone or are a known steroid responder

5. Have a history of ocular inflammation or macular edema

6. Are currently being treated with immunomodulating agents in the study eye(s)

7. Are currently being treated with immunosuppressants and/or oral steroids

8. Are currently being treated with corticosteroid implant (i.e. Ozurdex)

9. Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye

10. Have a history of complete punctal occlusion in one or both punctum

11. Currently use topical ophthalmic steroid medications

12. Are currently pregnant or nursing.

13. Are unwilling or unable to comply with the study protocol

14. Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) or if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wyse Eyecare

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wyse Eyecare

Northbrook, Illinois, United States

Countries

United States

Other Identifiers

WCG IRB Protocol #20225859

Identifier Type: -

Identifier Source: org_study_id