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

• Sponsor: Johnson & Johnson Surgical Vision, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03708367
• Collaborator: (none)
• Enrollment: 117
• Locations: 5
• Arms: 2
• Actual Duration (Months): 14.9
• Patients Per Site: 23.4
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cataracts; Meibomian Gland Dysfunction (MGD)	Device: LipiFlow Thermal Pulsation System; Device: LipiFlow Thermal Pulsation System	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 117 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice
• Actual Study Start Date: Oct 16, 2018
• Actual Primary Completion Date: Jan 13, 2020
• Actual Study Completion Date: Jan 13, 2020

Arms and Interventions

Arm	Intervention/Treatment
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
Other: Control 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

Outcome Measures

Primary Outcome Measures

1. 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).

2. Precision (Standard Deviation) of Preoperative Keratometric Measurements [2-4 weeks after first Pre-operative visit]

   Biometry testing was done pre-operatively

3. Precision of Axial Length (AL) and Anterior Chamber Depth (ACD) [2-4 weeks after first Pre-operative visit]

   Biometry testing was done pre-operatively

4. 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.

5. Rate of Bothersome Ocular Symptoms [3 months postoperative]

   Patient-Reported Visual Symptom Questionnaire (PRVSQ) Rating Results at 3 months postoperative

6. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria (all criteria apply to each study eye):

• Minimum 22 years of age.

• Bilateral cataracts for which phacoemulsification extraction and implantation with Symfony IOLs have been planned.

• Evidence of Meibomian Gland Dysfunction (MGD) in both eyes based on assessment of meibomian glands of the lower eyelid

• None to moderate dry eye symptoms with questionnaire

• Clear intraocular media other than cataract in each eye.

• Availability, willingness, ability and sufficient cognitive awareness to comply with the study protocol including: randomization; examination procedures; completion of planned bilateral cataract surgeries; compliance with no use of other MGD or dry eye treatments.

• Ability to understand, read and write English to consent to study participation and complete study questionnaires.

• Willingness to sign informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing country.

Exclusion Criteria (all criteria apply to each study eye):

• Any medical finding that would predictably result in a postoperative best corrected distance visual acuity worse than 20/30 in either eye.

• Use of systemic or ocular medications that, in the opinion of the investigator, may affect vision or impact pupil dilation or iris structure.

• Irregular corneal astigmatism.

• Any clinically-significant corneal pathology / abnormality other than regular corneal astigmatism.

• Any clinically-significant pupil abnormalities.

• Subjects with conditions associated with increased risk of zonular rupture.

• Unwillingness or inability to stop wearing contact lens at least two weeks prior to the baseline visit.

• Known ocular disease or pathology that, in the opinion of the investigator, may affect visual acuity or require surgical intervention during the study.

• Systemic disease condition that causes dry eye.

• Unwillingness or inability to abstain from the use of systemic medications known to cause dryness for the study duration. Subjects must have discontinued these medications for at least 1 month prior to Preoperative Visit.

• Unwillingness or inability to abstain from the use of systemic antihistamines.

• Unwillingness or inability to abstain from use of prescription medications for treatment of MGD or dry eye. Subject must have dicontinued using prescription medications for MGD or dry eye at least 1 month prior to baseline preoperative visit #1 measurements.

• Any of the following ocular (eye or eyelid) conditions in either eye within 3 months prior to the LipiFlow treatment visit:

• Prior intraocular, oculoplastic, corneal or refractive surgery procedure (LASIK, LASEK, RK, PRK, etc.).

• Ocular trauma.

• Ocular Herpes simplex or Herpes zoster (eye or eyelid) infection.

• History of recurrent ocular inflammation.

• Punctal plug insertion or punctal occlusion.

• Any of the following active ocular (eye or eyelid) conditions in either eye at the baseline Preoperative Visit #1 measurements:

• Ocular infection.

• Ocular inflammation.

• Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis

• Severe (Grade 3 or 4) inflammation of the eyelid.

• Eyelid abnormalities that affect lid function.

• Ocular surface abnormality that may compromise corneal integrity.

• Concurrent participation or participation within 30 days prior to study visit in any other clinical trial.

• Planned monovision correction.

• Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Empire Eye & Laser Center, Inc.	Bakersfield	California	United States	93309
2	Eye Doctors of Washington	Chevy Chase	Maryland	United States	20815
3	Matossian Eye Associates	Pennington	New Jersey	United States	08534
4	JW Eye Associates, P.A.	Dallas	Texas	United States	75243
5	Texas Eye & Laser Center, P.A.	Hurst	Texas	United States	76054

Sponsors and Collaborators

• Johnson & Johnson Surgical Vision, Inc.

Investigators

• Study Director: Priya Janakiraman, OD, Johnson & Johnson Surgical Vision, Inc.

Study Documents (Full-Text)

• Study Protocol - Nov 19, 2018
• Statistical Analysis Plan - Nov 16, 2018

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Surgical Vision, Inc.
• ClinicalTrials.gov Identifier: NCT03708367
• Other Study ID Numbers: DRYE-102-SELF
• First Posted: Oct 17, 2018
• Last Update Posted: Apr 27, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Cataract; Meibomian Gland Dysfunction

Study Results

Participant Flow

Pre-assignment Detail

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
Arm/Group Description	LipiFlow treatment at Pre-operative	LipiFlow treatment following 3-month visit
Period Title: Overall Study
STARTED	59	58
COMPLETED	58	57
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Study Group	Control Group	Total
Arm/Group Description	LipiFlow treatment at Pre-operative	LipiFlow treatment following 3-month visit	Total of all reporting groups
Overall Participants	59	58	117
Overall Eyes	117	115	232
Age, Customized (Number) [Number]
30-39 years	1 1.7%	0 0%	1 0.9%
40-49 years	1 1.7%	1 1.7%	2 1.7%
50-59 years	13 22%	10 17.2%	23 19.7%
60-69 years	28 47.5%	31 53.4%	59 50.4%
>=70 years	16 27.1%	16 27.6%	32 27.4%
Sex: Female, Male (Count of Participants)
Female	34 57.6%	35 60.3%	69 59%
Male	25 42.4%	23 39.7%	48 41%
Ethnicity (NIH/OMB) (Count of 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%
Race/Ethnicity, Customized (Number) [Number]
Asian (Including Indian)	3 5.1%	4 6.9%	7 6%
Black	8 13.6%	12 20.7%	20 17.1%
Caucasian	48 81.4%	42 72.4%	90 76.9%

Outcome Measures

1. Primary Outcome

Title	Mean Monocular UCDVA (Uncorrected Distance Visual Acuity)
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

Outcome Measure Data

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
Arm/Group Description	LipiFlow treatment at Pre-operative	LipiFlow treatment following 3-month visit
Measure Participants	58	57
Measure Eyes	116	114
Mean (Standard Deviation) [LogMAR]	0.08 (0.15)	0.07 (0.13)

2. Primary Outcome

Title	Precision (Standard Deviation) of Preoperative Keratometric Measurements
Description	Biometry testing was done pre-operatively
Time Frame	2-4 weeks after first Pre-operative visit

Outcome Measure Data

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
Arm/Group Description	LipiFlow treatment at Pre-operative	LipiFlow treatment following 3-month visit
Measure Participants	56	58
Measure Eyes	112	116
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)
Description	Biometry testing was done pre-operatively
Time Frame	2-4 weeks after first Pre-operative visit

Outcome Measure Data

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
Arm/Group Description	LipiFlow treatment at Pre-operative	LipiFlow treatment following 3-month visit
Measure Participants	56	58
Measure Eyes	112	116
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
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.

Outcome Measure Data

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
Arm/Group Description	LipiFlow treatment at Pre-operative	LipiFlow treatment following 3-month visit
Measure Participants	58	57
Measure Eyes	116	114
+/- 0.50 D	73.3	82.5
+/- 1.00 D	94.0	98.2

5. Primary Outcome

Title	Rate of Bothersome Ocular Symptoms
Description	Patient-Reported Visual Symptom Questionnaire (PRVSQ) Rating Results at 3 months postoperative
Time Frame	3 months postoperative

Outcome Measure Data

Analysis Population Description

Questionnaires were completed by bilaterally implanted participants.

Arm/Group Title	Study Group	Control Group
Arm/Group Description	LipiFlow treatment at Pre-operative	LipiFlow treatment following 3-month visit
Measure Participants	58	57
Q1a) Halos over the last 7 days	34 57.6%	45 77.6%
Q2a) Starburst over the last 7 days	36 61%	40 69%
Q3a) Multiple or Double vision over the last 7 days	15 25.4%	5 8.6%
Q4a) Sensitivity to Light over the last 7 days	38 64.4%	33 56.9%
Q5a) Glare related to scattered light over the last 7 days	20 33.9%	28 48.3%
Q6a) Occlusions over the last 7 days	1 1.7%	2 3.4%
Q7a) Poor Low Light Vision over the last 7 days	36 61%	33 56.9%

6. Primary Outcome

Title	Mean Change in Total Meibomian Gland Score From Baseline to 1 Month Postoperative
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.

Outcome Measure Data

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
Arm/Group Description	LipiFlow treatment at Pre-operative	LipiFlow treatment following 3-month visit
Measure Participants	57	57
Measure Eyes	114	114
Mean (Standard Deviation) [Units on a scale]	4.8 (8.2)	3.9 (8.3)

Adverse Events

Time Frame	3 months for study group and 4 months for available control group
Arm/Group Title	Study Group		Control Group		Control Group
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		0/58 (0%)		0/56 (0%)
Serious Adverse Events
	Study Group		Control Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/59 (5.1%)		4/58 (6.9%)		1/56 (1.8%)
Cardiac disorders
Hospitalization-ischemic event	0/59 (0%)	0	1/58 (1.7%)	1	0/56 (0%)	0
Eye disorders
Anterior Capsular Phimosis	0/59 (0%)	0	0/58 (0%)	0	1/56 (1.8%)	1
Cystoid Macular Edema	1/59 (1.7%)	1	2/58 (3.4%)	3	0/56 (0%)	0
Infections and infestations
Hospitalization- shingles	0/59 (0%)	0	1/58 (1.7%)	1	0/56 (0%)	0
Injury, poisoning and procedural complications
Hospitalization- fall related to dehydration	1/59 (1.7%)	1	0/58 (0%)	0	0/56 (0%)	0
Surgical and medical procedures
Hospitalization - Neck procedure	1/59 (1.7%)	1	0/58 (0%)	0	0/56 (0%)	0
Other (Not Including Serious) Adverse Events
	Study Group		Control Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/59 (0%)		2/58 (3.4%)		5/56 (8.9%)
Surgical and medical procedures
Undesirable Optical Phenomena	0/59 (0%)	0	2/58 (3.4%)	2	5/56 (8.9%)	5

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The sponsor must review results communication prior to public release and can embargo communications regarding trial results at anytime.