Clinical trial NCT04863742: Evaluation Of Vision Recovery And Comfort Index In Patients With Borderline/Mild Dry Eyes Undergoing FLACS With Premium IOL
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dry Eye Syndromes
Lead sponsor: Sight Medical Doctors PLLC
Sponsor class: OTHER
Collaborators: name: Ocular Therapeutix, Inc.
First posted: 2021-04-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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%.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA)
timeFrame: Baseline, Post-Operative Day 7 and Day 30
measure: Mean change in uncorrected Visual Acuity (VA)
timeFrame: Baseline, Post-Operative Day 7 and Day 30
measure: Mean change from baseline in Standardized Patient Evaluation of Eye Dryness (SPEED) score
timeFrame: Baseline, Post-Operative Day 7 and Day 30
Secondary outcomes:
measure: Patient satisfaction with vision at 1 week and 30 days after surgery
timeFrame: Post-Operative Day 7 and Day 30
measure: Mean number of artificial tear drops dosed per day
timeFrame: 30 Day tear log.
measure: Mean change in tear break-up time (TBUT)
timeFrame: Baseline and at POD 7 and POD 30
measure: Mean change in tear osmolarity
timeFrame: Baseline and at POD 7 and POD 30
measure: Mean change in corneal staining
timeFrame: Baseline and at POD 7 and POD 30
measure: Mean change from baseline in (Central Subfield Thickness) CST
timeFrame: Post-Operative Day 7 and 30
Other outcomes:
Locations:
city: Brentwood
country: United States
facility: SightMD, LIASC
state: New York
Study officials:
affiliation: Sight Medical Doctors PLLC
name: John Passarelli, MD
role: PRINCIPAL_INVESTIGATOR
References: