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

Dry Eye Syndromes Clinical Trial

— ENHANCE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04863742
• Other study ID #: ENHANCE
• Status: Recruiting
• Phase: Phase 4
• Start date: April 26, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: April 2021
• Source: Sight Medical Doctors PLLC
• Contact: John Passarelli, MD
• Phone: 6312314455
• Email: msingleton[@]sightmd.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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%.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 30, 2021
• Est. primary completion date: July 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Dextenza 0.4Mg Ophthalmic Insert
sustained released dexamethasone, 0.4mg
• Prednisolone Acetate
Prednisolone Acetate 1% QID x 1week, TID x 1week, BID x1 week, QD x1 week.

Locations

Country	Name	City	State
United States	SightMD, LIASC	Brentwood	New York

Sponsors (2)

Lead Sponsor	Collaborator
Sight Medical Doctors PLLC	Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA)	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
Primary	Mean change in uncorrected Visual Acuity (VA)	As measured by uncorrected VA from baseline and at 1 week and 30 days after surgery	Baseline, Post-Operative Day 7 and Day 30
Primary	Mean change from baseline in Standardized Patient Evaluation of Eye Dryness (SPEED) score	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	Patient satisfaction with vision at 1 week and 30 days after surgery	As measured by patient satisfaction survey	Post-Operative Day 7 and Day 30
Secondary	Mean number of artificial tear drops dosed per day	As measured by patient daily log.	30 Day tear log.
Secondary	Mean change in tear break-up time (TBUT)	As measured by TBUT	Baseline and at POD 7 and POD 30
Secondary	Mean change in tear osmolarity	As measured by tear osmolarity	Baseline and at POD 7 and POD 30
Secondary	Mean change in corneal staining	As measured by corneal staining	Baseline and at POD 7 and POD 30
Secondary	Mean change from baseline in (Central Subfield Thickness) CST	As measured by CST	Post-Operative Day 7 and 30