A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice
- Conditions
- CataractsMeibomian Gland Dysfunction (MGD)
- Interventions
- Device: LipiFlow Thermal Pulsation System
- Registration Number
- NCT03708367
- Lead Sponsor
- Johnson & Johnson Surgical Vision, Inc.
- Brief Summary
This is a post-market, prospective, randomized, multi-center, bilateral, open-label, cross-over, comparative clinical study. Study group will undergo preoperative LipiFlow treatment and Control group will not receive preoperative LipiFlow treatment. Three months postoperatively, both groups will be evaluated for clinical outcomes and the Control group will receive LipiFlow treatment as the cross-over group. The Control group will be evaluated at 4 months postoperative for clinical outcomes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 117
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Study Group: LipiFlow Treatment at PreOp LipiFlow Thermal Pulsation System Study subjects that meet all inclusion and exclusion criteria will be randomized to receive LipiFlow Thermal Pulsation System treatment at preoperative visit before bilateral implantation with commercially-available Symfony Intraocular Lens Control Group LipiFlow Thermal Pulsation System Study subjects that meet all inclusion and exclusion criteria will be randomized to not receive the LipiFlow Thermal Pulsation System treatment at a preoperative visit before bilaterally implanted with the commercially available Symfony Intraocular Lens. Control Group will receive LipiFlow treatment as cross-over group at 3 months postoperative visit.
- Primary Outcome Measures
Name Time Method Precision (Standard Deviation) of Preoperative Keratometric Measurements 2-4 weeks after first Pre-operative visit Biometry testing was done pre-operatively
Rate of Refractive Predictability Difference between Baseline visit and Postoperative visit at 10-14 weeks after cataract surgery on the second eye. Percentage of eyes with achieved manifest refractive spherical equivalence (MRSE) within +/- 0.50 D and +/- 1.00 D.
Achieved MRSE for each eye is defined as postoperative MRSE minus targeted MRSE.Rate of Bothersome Ocular Symptoms 3 months postoperative Patient-Reported Visual Symptom Questionnaire (PRVSQ) Rating Results at 3 months postoperative
Mean Monocular UCDVA (Uncorrected Distance Visual Acuity) 3 months Postoperative Uncorrected Distance Visual Acuity was measured for the Study and Control groups at the 3-month visit using the Clinical Trial Suite (M\&S Technologies) at 4.0 meters under photopic conditions (\~85 cd/m2).
Precision of Axial Length (AL) and Anterior Chamber Depth (ACD) 2-4 weeks after first Pre-operative visit Biometry testing was done pre-operatively
Mean Change in Total Meibomian Gland Score From Baseline to 1 Month Postoperative Preoperative Visit (Baseline) and Postoperative Visit between 30-60 days after cataract surgery on the second eye. Total Meibomian Gland Score: Fifteen Meibomian Glands (five temporally, centrally and nasally) in the lower eye are assessed on a scale of 0 - 3 (0 - No secretion, 1 - Inspissated (toothpaste consistency), 2 - Colored/cloudy liquid secretion or 3 - Clear liquid oil secretion). The sum of all 15 glands constitute the total meibomian gland secretion score (range 0-45).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
JW Eye Associates, P.A.
🇺🇸Dallas, Texas, United States
Texas Eye & Laser Center, P.A.
🇺🇸Hurst, Texas, United States
Matossian Eye Associates
🇺🇸Pennington, New Jersey, United States
Eye Doctors of Washington
🇺🇸Chevy Chase, Maryland, United States
Empire Eye & Laser Center, Inc.
🇺🇸Bakersfield, California, United States