A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice

Not Applicable

Completed

• Conditions: Cataracts; Meibomian Gland Dysfunction (MGD)

• 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

Study Timeline

• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-12
• Study Start: 2018-10-16
• Study First Posted: 2018-10-17
• Primary Completion: 2020-01-13
• Study Completion: 2020-01-13
• Results First Submitted: 2021-01-08
• Status Verified: 2021-03
• Results First Submitted QC: 2021-04-01
• Last Update Submitted: 2021-04-01
• Results First Posted: 2021-04-27
• Last Update Posted: 2021-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

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).

Trial Locations

Locations (5)

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

Texas Eye & Laser Center, P.A.; 🇺🇸 Hurst, Texas, United States