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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: Dextenza 0.4Mg Ophthalmic Insert
* Drug: Prednisolone Acetate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Nucleus sclerosis up to 2+ planning to undergo FLACS + Premium PCIOL in both eyes. Ability to provide informed consent for procedures Ability to attend scheduled follow up visits No other corneal pathology to create unknown variability Exclusion Criteria: Age less than 18 Pregnancy/currently breast-feeding Inability to provide informed consent Documented adverse reaction to steroid (e.g. steroid responder, allergy, etc) Punctal stenosis Previous corneal transplant surgery or refractive surgery Concurrent use of topical steroid eye drops Systemic, topical or intravitreal steroid use within 1 month of baseline Active history of chronic or recurrent inflammatory eye disease in either eye History of ocular herpetic infection (inclusive of Herpes Simplex 1/2, Varicella Zoster, Epstein Barr, Cytomegalovirus) History of neurotrophic keratitis, uncontrolled diabetes, or other disease entities that may preclude proper healing Diagnosis of Glaucoma or use of topical glaucoma drops Participation in other studies in the last 6 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

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