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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
117
Treatment at preoperative visit for study group
Treatment at 3 month visit as the cross-over group
Empire Eye & Laser Center, Inc.
Bakersfield, California, United States
Eye Doctors of Washington
Chevy Chase, Maryland, United States
Matossian Eye Associates
Pennington, New Jersey, United States
JW Eye Associates, P.A.
Dallas, Texas, United States
Mean Monocular UCDVA (Uncorrected Distance Visual Acuity)
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).
Time frame: 3 months Postoperative
Precision (Standard Deviation) of Preoperative Keratometric Measurements
Biometry testing was done pre-operatively
Time frame: 2-4 weeks after first Pre-operative visit
Precision of Axial Length (AL) and Anterior Chamber Depth (ACD)
Biometry testing was done pre-operatively
Time frame: 2-4 weeks after first Pre-operative visit
Rate of Refractive Predictability
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.
Time frame: Difference between Baseline visit and Postoperative visit at 10-14 weeks after cataract surgery on the second eye.
Rate of Bothersome Ocular Symptoms
Patient-Reported Visual Symptom Questionnaire (PRVSQ) Rating Results at 3 months postoperative
Time frame: 3 months postoperative
Mean Change in Total Meibomian Gland Score From Baseline to 1 Month Postoperative
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).
Time frame: Preoperative Visit (Baseline) and Postoperative Visit between 30-60 days after cataract surgery on the second eye.
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Texas Eye & Laser Center, P.A.
Hurst, Texas, United States