Evaluation Of Vision Recovery And Comfort Index In Patients With Borderline/Mild Dry Eyes Undergoing FLACS With Premium IOL
ENHANCE
1 other identifier
interventional
30
1 country
1
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%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Apr 2021
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2021
CompletedStudy Start
First participant enrolled
April 26, 2021
CompletedFirst Posted
Study publicly available on registry
April 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedApril 28, 2021
April 1, 2021
3 months
April 22, 2021
April 26, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (6)
Patient satisfaction with vision at 1 week and 30 days after surgery
Post-Operative Day 7 and Day 30
Mean number of artificial tear drops dosed per day
30 Day tear log.
Mean change in tear break-up time (TBUT)
Baseline and at POD 7 and POD 30
Mean change in tear osmolarity
Baseline and at POD 7 and POD 30
Mean change in corneal staining
Baseline and at POD 7 and POD 30
- +1 more secondary outcomes
Study Arms (2)
Dextenza Arm
EXPERIMENTALPrednisolone Acetate 1%
ACTIVE COMPARATORInterventions
Prednisolone Acetate 1% QID x 1week, TID x 1week, BID x1 week, QD x1 week.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sight Medical Doctors PLLClead
- Ocular Therapeutix, Inc.collaborator
Study Sites (1)
SightMD, LIASC
Brentwood, New York, 11717, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Passarelli, MD
Sight Medical Doctors PLLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
April 22, 2021
First Posted
April 28, 2021
Study Start
April 26, 2021
Primary Completion
July 31, 2021
Study Completion
September 30, 2021
Last Updated
April 28, 2021
Record last verified: 2021-04