A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice
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|ClinicalTrials.gov Identifier: NCT03708367|
Recruitment Status : Completed
First Posted : October 17, 2018
Results First Posted : April 27, 2021
Last Update Posted : April 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cataracts Meibomian Gland Dysfunction (MGD)||Device: LipiFlow Thermal Pulsation System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||117 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice|
|Actual Study Start Date :||October 16, 2018|
|Actual Primary Completion Date :||January 13, 2020|
|Actual Study Completion Date :||January 13, 2020|
Experimental: Study Group: LipiFlow Treatment at PreOp
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
Device: LipiFlow Thermal Pulsation System
Treatment at preoperative visit for study group
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.
Device: LipiFlow Thermal Pulsation System
Treatment at 3 month visit as the cross-over group
- Mean Monocular UCDVA (Uncorrected Distance Visual Acuity) [ Time Frame: 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 (Standard Deviation) of Preoperative Keratometric Measurements [ Time Frame: 2-4 weeks after first Pre-operative visit ]Biometry testing was done pre-operatively
- Precision of Axial Length (AL) and Anterior Chamber Depth (ACD) [ Time Frame: 2-4 weeks after first Pre-operative visit ]Biometry testing was done pre-operatively
- Rate of Refractive Predictability [ Time Frame: 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 [ Time Frame: 3 months postoperative ]Patient-Reported Visual Symptom Questionnaire (PRVSQ) Rating Results at 3 months postoperative
- Mean Change in Total Meibomian Gland Score From Baseline to 1 Month Postoperative [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03708367
|United States, California|
|Empire Eye & Laser Center, Inc.|
|Bakersfield, California, United States, 93309|
|United States, Maryland|
|Eye Doctors of Washington|
|Chevy Chase, Maryland, United States, 20815|
|United States, New Jersey|
|Matossian Eye Associates|
|Pennington, New Jersey, United States, 08534|
|United States, Texas|
|JW Eye Associates, P.A.|
|Dallas, Texas, United States, 75243|
|Texas Eye & Laser Center, P.A.|
|Hurst, Texas, United States, 76054|
|Study Director:||Priya Janakiraman, OD||Johnson & Johnson Surgical Vision, Inc.|