Clinical trial NCT03708367: A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice
Official title: A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataracts
Meibomian Gland Dysfunction (MGD)
Lead sponsor: Johnson & Johnson Surgical Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2018-10-17
Enrollment: 117
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Mean Monocular UCDVA (Uncorrected Distance Visual Acuity)
timeFrame: 3 months Postoperative
measure: Precision (Standard Deviation) of Preoperative Keratometric Measurements
timeFrame: 2-4 weeks after first Pre-operative visit
measure: Precision of Axial Length (AL) and Anterior Chamber Depth (ACD)
timeFrame: 2-4 weeks after first Pre-operative visit
measure: Rate of Refractive Predictability
timeFrame: Difference between Baseline visit and Postoperative visit at 10-14 weeks after cataract surgery on the second eye.
measure: Rate of Bothersome Ocular Symptoms
timeFrame: 3 months postoperative
measure: Mean Change in Total Meibomian Gland Score From Baseline to 1 Month Postoperative
timeFrame: Preoperative Visit (Baseline) and Postoperative Visit between 30-60 days after cataract surgery on the second eye.
Secondary outcomes:
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Empire Eye & Laser Center, Inc.
state: California
city: Chevy Chase
country: United States
facility: Eye Doctors of Washington
state: Maryland
city: Pennington
country: United States
facility: Matossian Eye Associates
state: New Jersey
city: Dallas
country: United States
facility: JW Eye Associates, P.A.
state: Texas
city: Hurst
country: United States
facility: Texas Eye & Laser Center, P.A.
state: Texas
Study officials:
affiliation: Johnson & Johnson Surgical Vision, Inc.
name: Priya Janakiraman, OD
role: STUDY_DIRECTOR
References: