A Study for Post op Inflammation After Cataract Surgery

Phase 4

• Conditions: Cataract
• Interventions: Drug: Prednisolone Acetate 1%; Drug: Dextenza 0.4Mg Ophthalmic Insert

• Registration Number: NCT05665270
• Lead Sponsor: Wyse Eyecare

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.

Study Timeline

• Study First Submitted: 2022-11-10
• Study First Submitted QC: 2022-12-15
• Study First Posted: 2022-12-27
• Study Start: 2023-01-30
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-26
• Primary Completion: 2023-10-31
• Study Completion: 2023-12-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisolone Acetate	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.
Dextenza	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).

Primary Outcome Measures

Name	Time	Method
Absence of anterior chamber cells	at Day 14	SUN Scale (0 minimum/better to 4 maximum/ worse)

Secondary Outcome Measures

Name	Time	Method
BCVA	Baseline (day 8) to day 37	Snellen Chart
Measuring Cell	Day 8, 14, 37	Sun Scale (0 minimum/better to 4 maximum/ worse)
Eye Pain	Day 8, 14, 37	VAS Questionnaire 0 no pain to 10 worst possible pain
Ease of Visualization	Day 8, 14, 37	Noted as Easy, Moderate, or Difficult
Dry Eye	Day 8, Day 14, and Day 37.	SPEED Survey Lower score indicates less dryness which is better than a higher score
Central Macular Thickness	Baseline to Day 37	Mean change of Central Macular Thickness by Optical coherence tomography
Insert Retention	Day 8 to 37 days	By slit lamp exam if insert is visualized or not
Number of subjects requiring rescue steroid	Day 8 to Day 37	Addition of steroid treatment
Number of attempts to successfully insertion	Day 8	Note Number of attempts to successfully insert as 1,2,3 attempts
Number and Percentage of subjects with complete absence of cell	Day 8 to 37	SUN Scale
Measuring Flare	Day 8, 14, 37	Sun Scale (0 minimum/better to 4 maximum/ worse)
Ease of insertion	Day 8	Noted as Easy, Moderate, or Difficult

Trial Locations

Locations (1)

Wyse Eyecare; 🇺🇸 Northbrook, Illinois, United States