A Study for Post op Inflammation After Cataract Surgery

Sponsor
Wyse Eyecare (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05665270
Collaborator
(none)
40
1
2
3.4
11.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dextenza 0.4Mg Ophthalmic Insert
  • Drug: Prednisolone Acetate 1%
Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment
Anticipated Study Start Date :
Jan 30, 2023
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
May 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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).

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.

Active Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Absence of anterior chamber cells [at Day 14]

    SUN Scale (0 minimum/better to 4 maximum/ worse)

Secondary Outcome Measures

  1. BCVA [Baseline (day 8) to day 37]

    Snellen Chart

  2. Number of subjects requiring rescue steroid [Day 8 to Day 37]

    Addition of steroid treatment

  3. Number and Percentage of subjects with complete absence of cell [Day 8 to 37]

    SUN Scale

  4. Measuring Cell [Day 8, 14, 37]

    Sun Scale (0 minimum/better to 4 maximum/ worse)

  5. Measuring Flare [Day 8, 14, 37]

    Sun Scale (0 minimum/better to 4 maximum/ worse)

  6. Eye Pain [Day 8, 14, 37]

    VAS Questionnaire 0 no pain to 10 worst possible pain

  7. Ease of insertion [Day 8]

    Noted as Easy, Moderate, or Difficult

  8. Ease of Visualization [Day 8, 14, 37]

    Noted as Easy, Moderate, or Difficult

  9. Number of attempts to successfully insertion [Day 8]

    Note Number of attempts to successfully insert as 1,2,3 attempts

  10. Dry Eye [Day 8, Day 14, and Day 37.]

    SPEED Survey Lower score indicates less dryness which is better than a higher score

  11. Central Macular Thickness [Baseline to Day 37]

    Mean change of Central Macular Thickness by Optical coherence tomography

  12. Insert Retention [Day 8 to 37 days]

    By slit lamp exam if insert is visualized or not

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Wyse Eyecare Northbrook Illinois United States 60062

Sponsors and Collaborators

  • Wyse Eyecare

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wyse Eyecare
ClinicalTrials.gov Identifier:
NCT05665270
Other Study ID Numbers:
  • WCG IRB Protocol #20225859
First Posted:
Dec 27, 2022
Last Update Posted:
Jan 18, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 18, 2023