Clinical trial NCT05665270: A Study for Post op Inflammation After Cataract Surgery
Official title: A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cataract
Lead sponsor: Wyse Eyecare
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Absence of anterior chamber cells
timeFrame: at Day 14
Secondary outcomes:
measure: BCVA
timeFrame: Baseline (day 8) to day 37
measure: Number of subjects requiring rescue steroid
timeFrame: Day 8 to Day 37
measure: Number and Percentage of subjects with complete absence of cell
timeFrame: Day 8 to 37
measure: Measuring Cell
timeFrame: Day 8, 14, 37
measure: Measuring Flare
timeFrame: Day 8, 14, 37
measure: Eye Pain
timeFrame: Day 8, 14, 37
measure: Ease of insertion
timeFrame: Day 8
measure: Ease of Visualization
timeFrame: Day 8, 14, 37
measure: Number of attempts to successfully insertion
timeFrame: Day 8
measure: Dry Eye
timeFrame: Day 8, Day 14, and Day 37.
measure: Central Macular Thickness
timeFrame: Baseline to Day 37
measure: Insert Retention
timeFrame: Day 8 to 37 days
Other outcomes:
Locations:
city: Northbrook
country: United States
facility: Wyse Eyecare
state: Illinois
Study officials:
References: