A Study for Post op Inflammation After Cataract Surgery

Cataract Clinical Trial

Official title:

A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05665270
• Other study ID #: WCG IRB Protocol #20225859
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: January 30, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: April 2023
• Source: Wyse Eyecare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 15, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Wyse Eyecare	Northbrook	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Wyse Eyecare

Country where clinical trial is conducted

United States, 

Outcome

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