Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03708367
Recruitment Status : Completed
First Posted : October 17, 2018
Results First Posted : April 27, 2021
Last Update Posted : April 27, 2021
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Surgical Vision, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cataracts
Meibomian Gland Dysfunction (MGD)
Intervention Device: LipiFlow Thermal Pulsation System
Enrollment 117
Recruitment Details  
Pre-assignment Details 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).
Arm/Group Title Study Group Control Group
Hide Arm/Group Description LipiFlow treatment at Pre-operative LipiFlow treatment following 3-month visit
Period Title: Overall Study
Number of participants Number of units (Eyes) Number of participants Number of units (Eyes)
Started 59 117 58 115
Completed 58 116 57 114
Not Completed 1 1 1 1
Arm/Group Title Study Group Control Group Total
Hide Arm/Group Description LipiFlow treatment at Pre-operative LipiFlow treatment following 3-month visit Total of all reporting groups
Overall Number of Baseline Participants 59 58 117
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
117 115 232
Hide Baseline Analysis Population Description
All eyes that are randomized and implanted
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants 58 participants 117 participants
30-39 years 1 0 1
40-49 years 1 1 2
50-59 years 13 10 23
60-69 years 28 31 59
>=70 years 16 16 32
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 58 participants 117 participants
Female
34
  57.6%
35
  60.3%
69
  59.0%
Male
25
  42.4%
23
  39.7%
48
  41.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 58 participants 117 participants
Hispanic or Latino
2
   3.4%
3
   5.2%
5
   4.3%
Not Hispanic or Latino
57
  96.6%
55
  94.8%
112
  95.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 59 participants 58 participants 117 participants
Asian (Including Indian) 3 4 7
Black 8 12 20
Caucasian 48 42 90
1.Primary Outcome
Title Mean Monocular UCDVA (Uncorrected Distance Visual Acuity)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Results from both eyes from all randomized subjects were included. Not all subjects completed all tests.
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:
LipiFlow treatment at Pre-operative
LipiFlow treatment following 3-month visit
Overall Number of Participants Analyzed 58 57
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
116 114
Mean (Standard Deviation)
Unit of Measure: LogMAR
0.08  (0.15) 0.07  (0.13)
2.Primary Outcome
Title Precision (Standard Deviation) of Preoperative Keratometric Measurements
Hide Description Biometry testing was done pre-operatively
Time Frame 2-4 weeks after first Pre-operative visit
Hide Outcome Measure Data
Hide Analysis Population Description
Results from both eyes from all randomized subjects were included. Not all subjects completed all tests.
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:
LipiFlow treatment at Pre-operative
LipiFlow treatment following 3-month visit
Overall Number of Participants Analyzed 56 58
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
112 116
Mean (Standard Deviation)
Unit of Measure: diopter
Precision of Keratometry 1 (K1) 0.0  (0.09) -0.01  (0.07)
Precision of Keratometry 2 (K2) 0.0  (0.09) 0.0  (0.07)
3.Primary Outcome
Title Precision of Axial Length (AL) and Anterior Chamber Depth (ACD)
Hide Description Biometry testing was done pre-operatively
Time Frame 2-4 weeks after first Pre-operative visit
Hide Outcome Measure Data
Hide Analysis Population Description
Results from both eyes from all randomized subjects were included. Not all subjects completed all tests.
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:
LipiFlow treatment at Pre-operative
LipiFlow treatment following 3-month visit
Overall Number of Participants Analyzed 56 58
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
112 116
Mean (Standard Deviation)
Unit of Measure: mm
Precision of Axial Length (AL) 0.0  (0.02) 0.0  (0.01)
Precision of Anterior Chamber Depth (ACD) 0.0  (0.01) 0.0  (0.02)
4.Primary Outcome
Title Rate of Refractive Predictability
Hide Description

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.
Hide Outcome Measure Data
Hide Analysis Population Description
Results from both eyes from all randomized subjects were included. Not all subjects completed all tests.
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:
LipiFlow treatment at Pre-operative
LipiFlow treatment following 3-month visit
Overall Number of Participants Analyzed 58 57
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
116 114
Measure Type: Number
Unit of Measure: Percentage of eyes
+/- 0.50 D 73.3 82.5
+/- 1.00 D 94.0 98.2
5.Primary Outcome
Title Rate of Bothersome Ocular Symptoms
Hide Description Patient-Reported Visual Symptom Questionnaire (PRVSQ) Rating Results at 3 months postoperative
Time Frame 3 months postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
Questionnaires were completed by bilaterally implanted participants.
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:
LipiFlow treatment at Pre-operative
LipiFlow treatment following 3-month visit
Overall Number of Participants Analyzed 58 57
Measure Type: Count of Participants
Unit of Measure: Participants
Q1a) Halos over the last 7 days
34
  58.6%
45
  78.9%
Q2a) Starburst over the last 7 days
36
  62.1%
40
  70.2%
Q3a) Multiple or Double vision over the last 7 days
15
  25.9%
5
   8.8%
Q4a) Sensitivity to Light over the last 7 days
38
  65.5%
33
  57.9%
Q5a) Glare related to scattered light over the last 7 days
20
  34.5%
28
  49.1%
Q6a) Occlusions over the last 7 days
1
   1.7%
2
   3.5%
Q7a) Poor Low Light Vision over the last 7 days
36
  62.1%
33
  57.9%
6.Primary Outcome
Title Mean Change in Total Meibomian Gland Score From Baseline to 1 Month Postoperative
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
Results from both eyes from all randomized subjects were included. Not all subjects completed all tests.
Arm/Group Title Study Group Control Group
Hide Arm/Group Description:
LipiFlow treatment at Pre-operative
LipiFlow treatment following 3-month visit
Overall Number of Participants Analyzed 57 57
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
114 114
Mean (Standard Deviation)
Unit of Measure: Units on a scale
4.8  (8.2) 3.9  (8.3)
Time Frame 3 months for study group and 4 months for available control group
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Study Group Control Group Control Group
Hide Arm/Group Description LipiFlow treatment at Pre-operative Prior to LipiFlow treatment at 3-month visit AEs occurring after LipiFlow treatment
All-Cause Mortality
Study Group Control Group Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/59 (0.00%)      0/58 (0.00%)      0/56 (0.00%)    
Hide Serious Adverse Events
Study Group Control Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/59 (5.08%)      4/58 (6.90%)      1/56 (1.79%)    
Cardiac disorders       
Hospitalization-ischemic event *  0/59 (0.00%)  0 1/58 (1.72%)  1 0/56 (0.00%)  0
Eye disorders       
Anterior Capsular Phimosis *  0/59 (0.00%)  0 0/58 (0.00%)  0 1/56 (1.79%)  1
Cystoid Macular Edema *  1/59 (1.69%)  1 2/58 (3.45%)  3 0/56 (0.00%)  0
Infections and infestations       
Hospitalization- shingles *  0/59 (0.00%)  0 1/58 (1.72%)  1 0/56 (0.00%)  0
Injury, poisoning and procedural complications       
Hospitalization- fall related to dehydration *  1/59 (1.69%)  1 0/58 (0.00%)  0 0/56 (0.00%)  0
Surgical and medical procedures       
Hospitalization - Neck procedure *  1/59 (1.69%)  1 0/58 (0.00%)  0 0/56 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Study Group Control Group Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/59 (0.00%)      2/58 (3.45%)      5/56 (8.93%)    
Surgical and medical procedures       
Undesirable Optical Phenomena *  0/59 (0.00%)  0 2/58 (3.45%)  2 5/56 (8.93%)  5
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor must review results communication prior to public release and can embargo communications regarding trial results at anytime.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sanjeev Kasthurirangan, PhD
Organization: Johnson & Johnson Surgical Vision
Phone: +1 408 5335282
EMail: skasthur@ITS.JNJ.com
Layout table for additonal information
Responsible Party: Johnson & Johnson Surgical Vision, Inc.
ClinicalTrials.gov Identifier: NCT03708367    
Other Study ID Numbers: DRYE-102-SELF
First Submitted: October 8, 2018
First Posted: October 17, 2018
Results First Submitted: January 8, 2021
Results First Posted: April 27, 2021
Last Update Posted: April 27, 2021