Trial Outcomes & Findings for A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice (NCT NCT03708367)
NCT ID: NCT03708367
Last Updated: 2021-04-27
Results Overview
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).
COMPLETED
NA
117 participants
3 months Postoperative
2021-04-27
Participant Flow
All study subjects enrolled from the normal surgical cataract population with bilateral mild to moderate Meibomian Gland Dysfunction, scheduled for bilateral cataract surgeries with Symfony Intraocular Lens implantation, at 5 sites in the U.S.A. 143 Subjects were consented, 26 screen-failed and 117 were randomized and bilaterally implanted. 115 evaluable subjects completed the study (58 in the study group and 57 in the Control Group).
Unit of analysis: Eyes
Participant milestones
| Measure |
Study Group
LipiFlow treatment at Pre-operative
|
Control Group
LipiFlow treatment following 3-month visit
|
|---|---|---|
|
Overall Study
STARTED
|
59 117
|
58 115
|
|
Overall Study
COMPLETED
|
58 116
|
57 114
|
|
Overall Study
NOT COMPLETED
|
1 1
|
1 1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice
Baseline characteristics by cohort
| Measure |
Study Group
n=117 Eyes
LipiFlow treatment at Pre-operative
|
Control Group
n=115 Eyes
LipiFlow treatment following 3-month visit
|
Total
n=232 Eyes
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
30-39 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
40-49 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Customized
50-59 years
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
28 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Age, Customized
>=70 years
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
57 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian (Including Indian)
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
48 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months PostoperativePopulation: Results from both eyes from all randomized subjects were included. Not all subjects completed all tests.
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).
Outcome measures
| Measure |
Study Group
n=116 Eyes
LipiFlow treatment at Pre-operative
|
Control Group
n=114 Eyes
LipiFlow treatment following 3-month visit
|
|---|---|---|
|
Mean Monocular UCDVA (Uncorrected Distance Visual Acuity)
|
0.08 LogMAR
Standard Deviation 0.15
|
0.07 LogMAR
Standard Deviation 0.13
|
PRIMARY outcome
Timeframe: 2-4 weeks after first Pre-operative visitPopulation: Results from both eyes from all randomized subjects were included. Not all subjects completed all tests.
Biometry testing was done pre-operatively
Outcome measures
| Measure |
Study Group
n=112 Eyes
LipiFlow treatment at Pre-operative
|
Control Group
n=116 Eyes
LipiFlow treatment following 3-month visit
|
|---|---|---|
|
Precision (Standard Deviation) of Preoperative Keratometric Measurements
Precision of Keratometry 1 (K1)
|
0.0 diopter
Standard Deviation 0.09
|
-0.01 diopter
Standard Deviation 0.07
|
|
Precision (Standard Deviation) of Preoperative Keratometric Measurements
Precision of Keratometry 2 (K2)
|
0.0 diopter
Standard Deviation 0.09
|
0.0 diopter
Standard Deviation 0.07
|
PRIMARY outcome
Timeframe: 2-4 weeks after first Pre-operative visitPopulation: Results from both eyes from all randomized subjects were included. Not all subjects completed all tests.
Biometry testing was done pre-operatively
Outcome measures
| Measure |
Study Group
n=112 Eyes
LipiFlow treatment at Pre-operative
|
Control Group
n=116 Eyes
LipiFlow treatment following 3-month visit
|
|---|---|---|
|
Precision of Axial Length (AL) and Anterior Chamber Depth (ACD)
Precision of Axial Length (AL)
|
0.0 mm
Standard Deviation 0.02
|
0.0 mm
Standard Deviation 0.01
|
|
Precision of Axial Length (AL) and Anterior Chamber Depth (ACD)
Precision of Anterior Chamber Depth (ACD)
|
0.0 mm
Standard Deviation 0.01
|
0.0 mm
Standard Deviation 0.02
|
PRIMARY outcome
Timeframe: Difference between Baseline visit and Postoperative visit at 10-14 weeks after cataract surgery on the second eye.Population: Results from both eyes from all randomized subjects were included. Not all subjects completed all tests.
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.
Outcome measures
| Measure |
Study Group
n=116 Eyes
LipiFlow treatment at Pre-operative
|
Control Group
n=114 Eyes
LipiFlow treatment following 3-month visit
|
|---|---|---|
|
Rate of Refractive Predictability
+/- 0.50 D
|
73.3 Percentage of eyes
|
82.5 Percentage of eyes
|
|
Rate of Refractive Predictability
+/- 1.00 D
|
94.0 Percentage of eyes
|
98.2 Percentage of eyes
|
PRIMARY outcome
Timeframe: 3 months postoperativePopulation: Questionnaires were completed by bilaterally implanted participants.
Patient-Reported Visual Symptom Questionnaire (PRVSQ) Rating Results at 3 months postoperative
Outcome measures
| Measure |
Study Group
n=58 Participants
LipiFlow treatment at Pre-operative
|
Control Group
n=57 Participants
LipiFlow treatment following 3-month visit
|
|---|---|---|
|
Rate of Bothersome Ocular Symptoms
Q5a) Glare related to scattered light over the last 7 days
|
20 Participants
|
28 Participants
|
|
Rate of Bothersome Ocular Symptoms
Q1a) Halos over the last 7 days
|
34 Participants
|
45 Participants
|
|
Rate of Bothersome Ocular Symptoms
Q2a) Starburst over the last 7 days
|
36 Participants
|
40 Participants
|
|
Rate of Bothersome Ocular Symptoms
Q3a) Multiple or Double vision over the last 7 days
|
15 Participants
|
5 Participants
|
|
Rate of Bothersome Ocular Symptoms
Q4a) Sensitivity to Light over the last 7 days
|
38 Participants
|
33 Participants
|
|
Rate of Bothersome Ocular Symptoms
Q6a) Occlusions over the last 7 days
|
1 Participants
|
2 Participants
|
|
Rate of Bothersome Ocular Symptoms
Q7a) Poor Low Light Vision over the last 7 days
|
36 Participants
|
33 Participants
|
PRIMARY outcome
Timeframe: Preoperative Visit (Baseline) and Postoperative Visit between 30-60 days after cataract surgery on the second eye.Population: Results from both eyes from all randomized subjects were included. Not all subjects completed all tests.
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).
Outcome measures
| Measure |
Study Group
n=114 Eyes
LipiFlow treatment at Pre-operative
|
Control Group
n=114 Eyes
LipiFlow treatment following 3-month visit
|
|---|---|---|
|
Mean Change in Total Meibomian Gland Score From Baseline to 1 Month Postoperative
|
4.8 Units on a scale
Standard Deviation 8.2
|
3.9 Units on a scale
Standard Deviation 8.3
|
Adverse Events
Study Group
Control Group
Control Group
Serious adverse events
| Measure |
Study Group
n=59 participants at risk
LipiFlow treatment at Pre-operative
|
Control Group
n=58 participants at risk
Prior to LipiFlow treatment at 3-month visit
|
Control Group
n=56 participants at risk
AEs occurring after LipiFlow treatment
|
|---|---|---|---|
|
Eye disorders
Anterior Capsular Phimosis
|
0.00%
0/59 • 3 months for study group and 4 months for available control group
|
0.00%
0/58 • 3 months for study group and 4 months for available control group
|
1.8%
1/56 • Number of events 1 • 3 months for study group and 4 months for available control group
|
|
Eye disorders
Cystoid Macular Edema
|
1.7%
1/59 • Number of events 1 • 3 months for study group and 4 months for available control group
|
3.4%
2/58 • Number of events 3 • 3 months for study group and 4 months for available control group
|
0.00%
0/56 • 3 months for study group and 4 months for available control group
|
|
Surgical and medical procedures
Hospitalization - Neck procedure
|
1.7%
1/59 • Number of events 1 • 3 months for study group and 4 months for available control group
|
0.00%
0/58 • 3 months for study group and 4 months for available control group
|
0.00%
0/56 • 3 months for study group and 4 months for available control group
|
|
Injury, poisoning and procedural complications
Hospitalization- fall related to dehydration
|
1.7%
1/59 • Number of events 1 • 3 months for study group and 4 months for available control group
|
0.00%
0/58 • 3 months for study group and 4 months for available control group
|
0.00%
0/56 • 3 months for study group and 4 months for available control group
|
|
Infections and infestations
Hospitalization- shingles
|
0.00%
0/59 • 3 months for study group and 4 months for available control group
|
1.7%
1/58 • Number of events 1 • 3 months for study group and 4 months for available control group
|
0.00%
0/56 • 3 months for study group and 4 months for available control group
|
|
Cardiac disorders
Hospitalization-ischemic event
|
0.00%
0/59 • 3 months for study group and 4 months for available control group
|
1.7%
1/58 • Number of events 1 • 3 months for study group and 4 months for available control group
|
0.00%
0/56 • 3 months for study group and 4 months for available control group
|
Other adverse events
| Measure |
Study Group
n=59 participants at risk
LipiFlow treatment at Pre-operative
|
Control Group
n=58 participants at risk
Prior to LipiFlow treatment at 3-month visit
|
Control Group
n=56 participants at risk
AEs occurring after LipiFlow treatment
|
|---|---|---|---|
|
Surgical and medical procedures
Undesirable Optical Phenomena
|
0.00%
0/59 • 3 months for study group and 4 months for available control group
|
3.4%
2/58 • Number of events 2 • 3 months for study group and 4 months for available control group
|
8.9%
5/56 • Number of events 5 • 3 months for study group and 4 months for available control group
|
Additional Information
Sanjeev Kasthurirangan, PhD
Johnson & Johnson Surgical Vision
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must review results communication prior to public release and can embargo communications regarding trial results at anytime.
- Publication restrictions are in place
Restriction type: OTHER