A Study for Post op Inflammation After Cataract Surgery

• Status: Enrolling by invitation
• Trial end date: 2023-05-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Wyse Eyecare
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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