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

• 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: Johnson & Johnson Surgical Vision, Inc.
• Information provided by (Responsible Party): Johnson & Johnson Surgical Vision, Inc.

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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• 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: October 16, 2018
• Actual Primary Completion Date: January 13, 2020
• Actual Study Completion Date: January 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
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) [ 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).
2. Precision (Standard Deviation) of Preoperative Keratometric Measurements [ Time Frame: 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) [ Time Frame: 2-4 weeks after first Pre-operative visit ]
   Biometry testing was done pre-operatively
4. 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.

5. Rate of Bothersome Ocular Symptoms [ Time Frame: 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 [ 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).

Eligibility Criteria

• Ages Eligible for Study: 22 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

United States, California

Empire Eye & Laser Center, Inc.

Bakersfield, California, United States, 93309

United States, Maryland

Eye Doctors of Washington

Chevy Chase, Maryland, United States, 20815

United States, New Jersey

Matossian Eye Associates

Pennington, New Jersey, United States, 08534

United States, Texas

JW Eye Associates, P.A.

Dallas, Texas, United States, 75243

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)

Documents provided by Johnson & Johnson Surgical Vision, Inc.:

Study Protocol  [PDF] November 19, 2018

Statistical Analysis Plan  [PDF] November 16, 2018

More Information

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

Individual Participant Data (IPD) Sharing Statement:

• 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; Lens Diseases; Eye Diseases; Eyelid Diseases