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

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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.

Tracking Information
First Submitted Date  ICMJE October 8, 2018
First Posted Date  ICMJE October 17, 2018
Results First Submitted Date  ICMJE January 8, 2021
Results First Posted Date  ICMJE April 27, 2021
Last Update Posted Date April 27, 2021
Actual Study Start Date  ICMJE October 16, 2018
Actual Primary Completion Date January 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2021)
  • Mean Monocular UCDVA (Uncorrected Distance Visual Acuity) [ Time Frame: 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 (Standard Deviation) of Preoperative Keratometric Measurements [ Time Frame: 2-4 weeks after first Pre-operative visit ]
    Biometry testing was done pre-operatively
  • Precision of Axial Length (AL) and Anterior Chamber Depth (ACD) [ Time Frame: 2-4 weeks after first Pre-operative visit ]
    Biometry testing was done pre-operatively
  • Rate of Refractive Predictability [ Time Frame: 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 [ Time Frame: 3 months postoperative ]
    Patient-Reported Visual Symptom Questionnaire (PRVSQ) Rating Results at 3 months postoperative
  • Mean Change in Total Meibomian Gland Score From Baseline to 1 Month Postoperative [ Time Frame: 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).
Original Primary Outcome Measures  ICMJE
 (submitted: October 12, 2018)
  • Uncorrected Distance Visual Acuity (UCDVA) [ Time Frame: 10 to 14 weeks postoperative ]
    Mean monocular UCDVA at 3 months postoperative in the Study and Control groups.
  • Rate of Refractive Predictability [ Time Frame: 10 to 14 weeks postoperative ]
    Rate of refractive predictability (i.e., within 0.50 D of target refraction, and within 1.00 D of target refraction) at 3 months postoperative.
  • Rate of Bothersome Ocular Symptoms [ Time Frame: 10 to 14 weeks preoperative ]
    Rate of directed bothersome ocular symptoms at 3 months postoperative.
  • Total Meibomian Gland Score [ Time Frame: 30 to 60 days postoperative ]
    Mean change in total meibomian gland score from Baseline to the 1-month (30 to 60 days) postoperative visit.
  • Precision of Preoperative Axial Length [ Time Frame: 0 to 8 weeks preoperative ]
    Precision (standard deviation) of preoperative axial length (AL).
  • Precision of Preoperative Anterior Chamber Depth [ Time Frame: 0 to 8 weeks preoperative ]
    Precision (standard deviation) of anterior chamber depth (ACD).
  • Precision of Keratometric Measurements [ Time Frame: 0 to 8 weeks preoperative ]
    Precision (standard deviation) of keratometric measurements (K).
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice
Official Title  ICMJE A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cataracts
  • Meibomian Gland Dysfunction (MGD)
Intervention  ICMJE
  • Device: LipiFlow Thermal Pulsation System
    Treatment at preoperative visit for study group
  • Device: LipiFlow Thermal Pulsation System
    Treatment at 3 month visit as the cross-over group
Study Arms  ICMJE
  • 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
    Intervention: Device: LipiFlow Thermal Pulsation System
  • 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.
    Intervention: Device: LipiFlow Thermal Pulsation System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2021)
117
Original Estimated Enrollment  ICMJE
 (submitted: October 12, 2018)
140
Actual Study Completion Date  ICMJE January 13, 2020
Actual Primary Completion Date January 13, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03708367
Other Study ID Numbers  ICMJE DRYE-102-SELF
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Johnson & Johnson Surgical Vision, Inc.
Study Sponsor  ICMJE Johnson & Johnson Surgical Vision, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Priya Janakiraman, OD Johnson & Johnson Surgical Vision, Inc.
PRS Account Johnson & Johnson Surgical Vision, Inc.
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP