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%.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
sustained released dexamethasone, 0.4mg
Prednisolone Acetate 1% QID x 1week, TID x 1week, BID x1 week, QD x1 week.
SightMD, LIASC
Brentwood, New York, United States
RECRUITINGMean 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
Time frame: 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
Time frame: 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
Time frame: Baseline, Post-Operative Day 7 and Day 30
Patient satisfaction with vision at 1 week and 30 days after surgery
As measured by patient satisfaction survey
Time frame: Post-Operative Day 7 and Day 30
Mean number of artificial tear drops dosed per day
As measured by patient daily log.
Time frame: 30 Day tear log.
Mean change in tear break-up time (TBUT)
As measured by TBUT
Time frame: Baseline and at POD 7 and POD 30
Mean change in tear osmolarity
As measured by tear osmolarity
Time frame: Baseline and at POD 7 and POD 30
Mean change in corneal staining
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Masking
NONE
Enrollment
30
As measured by corneal staining
Time frame: Baseline and at POD 7 and POD 30
Mean change from baseline in (Central Subfield Thickness) CST
As measured by CST
Time frame: Post-Operative Day 7 and 30