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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Group: LipiFlow Treatment at PreOp | Experimental | 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 |
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| Control Group | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LipiFlow Thermal Pulsation System | Device | Treatment at preoperative visit for study group |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Monocular UCDVA (Uncorrected Distance Visual Acuity) | 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). | 3 months Postoperative |
| Precision (Standard Deviation) of Preoperative Keratometric Measurements | Biometry testing was done pre-operatively | 2-4 weeks after first Pre-operative visit |
| Precision of Axial Length (AL) and Anterior Chamber Depth (ACD) | Biometry testing was done pre-operatively | 2-4 weeks after first Pre-operative visit |
| Rate of Refractive Predictability | 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. | Difference between Baseline visit and Postoperative visit at 10-14 weeks after cataract surgery on the second eye. |
| Rate of Bothersome Ocular Symptoms | Patient-Reported Visual Symptom Questionnaire (PRVSQ) Rating Results at 3 months postoperative | 3 months postoperative |
| Mean Change in Total Meibomian Gland Score From Baseline to 1 Month Postoperative | 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). |
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Inclusion Criteria (all criteria apply to each study eye):
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:
Any of the following active ocular (eye or eyelid) conditions in either eye at the baseline Preoperative Visit #1 measurements:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Priya Janakiraman, OD | Johnson & Johnson Surgical Vision, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Empire Eye & Laser Center, Inc. | Bakersfield | California | 93309 | United States | ||
| Eye Doctors of Washington |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37318707 | Derived | Matossian C, Chang DH, Whitman J, Clinch TE, Hu J, Ji L, Murakami D, Wang Y, Blackie CA. Preoperative Treatment of Meibomian Gland Dysfunction with a Vectored Thermal Pulsation System Prior to Extended Depth of Focus IOL Implantation. Ophthalmol Ther. 2023 Oct;12(5):2427-2439. doi: 10.1007/s40123-023-00740-x. Epub 2023 Jun 15. |
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Study Group | LipiFlow treatment at Pre-operative |
| FG001 | Control Group | LipiFlow treatment following 3-month visit |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 19, 2018 | Jan 8, 2021 |
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| LipiFlow Thermal Pulsation System | Device | Treatment at 3 month visit as the cross-over group |
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| Preoperative Visit (Baseline) and Postoperative Visit between 30-60 days after cataract surgery on the second eye. |
| Chevy Chase |
| Maryland |
| 20815 |
| United States |
| Matossian Eye Associates | Pennington | New Jersey | 08534 | United States |
| JW Eye Associates, P.A. | Dallas | Texas | 75243 | United States |
| Texas Eye & Laser Center, P.A. | Hurst | Texas | 76054 | United States |
| COMPLETED |
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| NOT COMPLETED |
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All eyes that are randomized and implanted
| ID | Title | Description |
|---|---|---|
| BG000 | Study Group | LipiFlow treatment at Pre-operative |
| BG001 | Control Group | LipiFlow treatment following 3-month visit |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Eyes |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Monocular UCDVA (Uncorrected Distance Visual Acuity) | 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). | Results from both eyes from all randomized subjects were included. Not all subjects completed all tests. | Posted | Mean | Standard Deviation | LogMAR | 3 months Postoperative | Eyes | Eyes |
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| Primary | Precision (Standard Deviation) of Preoperative Keratometric Measurements | Biometry testing was done pre-operatively | Results from both eyes from all randomized subjects were included. Not all subjects completed all tests. | Posted | Mean | Standard Deviation | diopter | 2-4 weeks after first Pre-operative visit | Eyes | Eyes |
|
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| Primary | Precision of Axial Length (AL) and Anterior Chamber Depth (ACD) | Biometry testing was done pre-operatively | Results from both eyes from all randomized subjects were included. Not all subjects completed all tests. | Posted | Mean | Standard Deviation | mm | 2-4 weeks after first Pre-operative visit | Eyes | Eyes |
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| Primary | Rate of Refractive Predictability | 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. | Results from both eyes from all randomized subjects were included. Not all subjects completed all tests. | Posted | Number | Percentage of eyes | Difference between Baseline visit and Postoperative visit at 10-14 weeks after cataract surgery on the second eye. | Eyes | Eyes |
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| ||||||||||||||||||||||||||||||
| Primary | Rate of Bothersome Ocular Symptoms | Patient-Reported Visual Symptom Questionnaire (PRVSQ) Rating Results at 3 months postoperative | Questionnaires were completed by bilaterally implanted participants. | Posted | Count of Participants | Participants | 3 months postoperative |
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| Primary | Mean Change in Total Meibomian Gland Score From Baseline to 1 Month Postoperative | 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). | Results from both eyes from all randomized subjects were included. Not all subjects completed all tests. | Posted | Mean | Standard Deviation | Units on a scale | Preoperative Visit (Baseline) and Postoperative Visit between 30-60 days after cataract surgery on the second eye. | Eyes | Eyes |
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3 months for study group and 4 months for available control group
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Group | LipiFlow treatment at Pre-operative | 0 | 59 | 3 | 59 | 0 | 59 |
| EG001 | Control Group | Prior to LipiFlow treatment at 3-month visit | 0 | 58 | 4 | 58 | 2 | 58 |
| EG002 | Control Group | AEs occurring after LipiFlow treatment | 0 | 56 | 1 | 56 | 5 | 56 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anterior Capsular Phimosis | Eye disorders | Non-systematic Assessment |
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| Cystoid Macular Edema | Eye disorders | Non-systematic Assessment |
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| Hospitalization - Neck procedure | Surgical and medical procedures | Non-systematic Assessment |
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| Hospitalization- fall related to dehydration | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Hospitalization- shingles | Infections and infestations | Non-systematic Assessment |
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| Hospitalization-ischemic event | Cardiac disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Undesirable Optical Phenomena | Surgical and medical procedures | Non-systematic Assessment |
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The sponsor must review results communication prior to public release and can embargo communications regarding trial results at anytime.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sanjeev Kasthurirangan, PhD | Johnson & Johnson Surgical Vision | +1 408 5335282 | skasthur@ITS.JNJ.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 16, 2018 | Jan 8, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D000080343 | Meibomian Gland Dysfunction |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D005141 | Eyelid Diseases |
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| Title | Measurements |
|---|---|
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| 50-59 years |
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| 60-69 years |
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| >=70 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Black |
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| Caucasian |
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| Eyes |
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| Eyes |
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| Eyes |
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| Eyes |
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