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

NCT03708367 | Completed Results FDA Device

• 1 other identifier: DRYE-102-SELF
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 5

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.

Conditions

Cataracts; Meibomian Gland Dysfunction (MGD)

Outcome Measures

Primary Outcomes (6)

• 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).

  Preoperative Visit (Baseline) and Postoperative Visit between 30-60 days after cataract surgery on the second eye.

Study Arms (2)

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

Device: LipiFlow Thermal Pulsation System

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.

Device: LipiFlow Thermal Pulsation System

Interventions

LipiFlow Thermal Pulsation System DEVICE

Treatment at preoperative visit for study group

Study Group: LipiFlow Treatment at PreOp

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Surgical Vision, Inc.: lead

Study Sites (5)

Empire Eye & Laser Center, Inc.

Bakersfield, California, 93309, United States

Location

Eye Doctors of Washington

Chevy Chase, Maryland, 20815, United States

Location

Matossian Eye Associates

Pennington, New Jersey, 08534, United States

Location

JW Eye Associates, P.A.

Dallas, Texas, 75243, United States

Location

Texas Eye & Laser Center, P.A.

Hurst, Texas, 76054, United States

Location

Related Publications (1)

• 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.

  PMID: 37318707 DERIVED

MeSH Terms

Conditions

Cataract; Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Eyelid Diseases

Results Point of Contact

• Title: Sanjeev Kasthurirangan, PhD
• Organization: Johnson & Johnson Surgical Vision

skasthur@ITS.JNJ.com

+1 408 5335282

Study Officials

• Priya Janakiraman, OD

  Johnson & Johnson Surgical Vision, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 17, 2018
• Study Start: October 16, 2018
• Primary Completion: January 13, 2020
• Study Completion: January 13, 2020
• Last Updated: April 27, 2021
• Results First Posted: April 27, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)