Evaluation Of Vision Recovery And Comfort Index In Patients With Borderline/Mild Dry Eyes Undergoing FLACS With Premium IOL (ENHANCE)

April 26, 2021 updated by: Dr. John Passarelli, Sight Medical Doctors PLLC

Evaluation Of Vision Recovery And Comfort Index In Patients With Borderline/Mild Dry Eyes Undergoing Femtosecond Laser-Assisted Cataract Surgery With Premium Intraocular Lens - The ENHANCE Study

This is a prospective, open-label, single-center, randomized, head-to-head, investigator-sponsored clinical study. It aims to investigate the vision recovery and patient comfort in borderline/mild dry eye disease patients undergoing FLACS with Premium PCIOL (i.e., Panoptix, Toric IOL (spherical/multifocal), ReStor, Symfony), receiving a 0.4mg dexamethasone intracanalicular insert when compared to patients receiving standard of care prednisolone acetate 1%.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, open-label, single-center, randomized, head-to-head, investigator-sponsored clinical study. It aims to investigate the vision recovery and patient comfort in borderline/mild dry eye disease patients undergoing FLACS with Premium PCIOL (i.e., Panoptix, Toric IOL (spherical/multifocal), ReStor, Symfony), receiving a 0.4mg dexamethasone intracanalicular insert when compared to patients receiving standard of care prednisolone acetate 1%. After screening a given patient for inclusion and exclusion criteria, and gaining informed consent, a total of 30 patients will be randomized into two groups:

Group 1: 15 patients will undergo bilateral FLACS + Premium PCIOL in separate days and will receive a 0.4mg dexamethasone intracanalicular insert at the days of each surgery.

Group 2: 15 patients will undergo bilateral FLACS + Premium PCIOL in separate days and will receive prednisolone acetate 1% QID/ 1 week, TID/ 1 week, BID/1 week, QD/ 1 week regimen starting at the days of each surgery.

All patient eyes will receive Prolensa 0.07% ophthalmic solution QD for 4 weeks starting 3 days prior to surgery and Besivance 0.6% eye drops TID/starting 3 days prior to surgery.

Per enrolled eye, the study period will last for approximately 30 days after surgery, consisting of three postop follow-up visits (six total postop visits per patient). At Day 1, Day 7 and Day 30, primary and secondary endpoints will be assessed alongside standard-of-care procedures. SPEED questionnaire will be assessed by a masked survey administrator. Adjusting for enrollment period, the study will last a total of approximately 12 months, including submission for publication/ presentation.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Demonstrate objective signs of Boderline/ Mild Ocular Surface Disease (OSD) [defined as mild symptoms, mild conjunctival staining (<2+ Superficial Punctate Keratitis), Tear Break-up Time <12s] or demonstrate symptoms of OSD determined by SPEED questionnaire (SPEED Score <10).
  2. Nucleus sclerosis up to 2+ planning to undergo FLACS + Premium PCIOL in both eyes.
  3. Ability to provide informed consent for procedures
  4. Ability to attend scheduled follow up visits
  5. No other corneal pathology to create unknown variability

Exclusion Criteria:

  1. Age less than 18
  2. Pregnancy/currently breast-feeding
  3. Inability to provide informed consent
  4. Documented adverse reaction to steroid (e.g. "steroid responder", allergy, etc)
  5. Punctal stenosis
  6. Previous corneal transplant surgery or refractive surgery
  7. Concurrent use of topical steroid eye drops
  8. Systemic, topical or intravitreal steroid use within 1 month of baseline
  9. Active history of chronic or recurrent inflammatory eye disease in either eye
  10. History of ocular herpetic infection (inclusive of Herpes Simplex 1/2, Varicella Zoster, Epstein Barr, Cytomegalovirus)
  11. History of neurotrophic keratitis, uncontrolled diabetes, or other disease entities that may preclude proper healing
  12. Diagnosis of Glaucoma or use of topical glaucoma drops
  13. Participation in other studies in the last 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dextenza Arm
Drug: Dextenza 0.4Mg Ophthalmic Insert
sustained released dexamethasone, 0.4mg
Active Comparator: Prednisolone Acetate 1%
Drug: Prednisolone Acetate
Prednisolone Acetate 1% QID x 1week, TID x 1week, BID x1 week, QD x1 week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA)
Time Frame: Baseline, Post-Operative Day 7 and Day 30
As measured by Best Corrected Visual Acuity (BCVA) from baseline and at 1 week and 30 days after surgery
Baseline, Post-Operative Day 7 and Day 30
Mean change in uncorrected Visual Acuity (VA)
Time Frame: Baseline, Post-Operative Day 7 and Day 30
As measured by uncorrected VA from baseline and at 1 week and 30 days after surgery
Baseline, Post-Operative Day 7 and Day 30
Mean change from baseline in Standardized Patient Evaluation of Eye Dryness (SPEED) score
Time Frame: Baseline, Post-Operative Day 7 and Day 30
As measured by SPEED score from baseline and at 1 week and 30 days after surgery
Baseline, Post-Operative Day 7 and Day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction with vision at 1 week and 30 days after surgery
Time Frame: Post-Operative Day 7 and Day 30
As measured by patient satisfaction survey
Post-Operative Day 7 and Day 30
Mean number of artificial tear drops dosed per day
Time Frame: 30 Day tear log.
As measured by patient daily log.
30 Day tear log.
Mean change in tear break-up time (TBUT)
Time Frame: Baseline and at POD 7 and POD 30
As measured by TBUT
Baseline and at POD 7 and POD 30
Mean change in tear osmolarity
Time Frame: Baseline and at POD 7 and POD 30
As measured by tear osmolarity
Baseline and at POD 7 and POD 30
Mean change in corneal staining
Time Frame: Baseline and at POD 7 and POD 30
As measured by corneal staining
Baseline and at POD 7 and POD 30
Mean change from baseline in (Central Subfield Thickness) CST
Time Frame: Post-Operative Day 7 and 30
As measured by CST
Post-Operative Day 7 and 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sight Medical Doctors PLLC

Collaborators

Ocular Therapeutix, Inc.

Investigators

  • Principal Investigator: John Passarelli, MD, Sight Medical Doctors PLLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 26, 2021

Primary Completion (Anticipated)

July 31, 2021

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

April 22, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Enhance

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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