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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

117 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-16

Study Completion Date

2020-01-13

Brief Summary

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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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Detailed Description

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Conditions

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Cataracts Meibomian Gland Dysfunction (MGD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

LipiFlow Thermal Pulsation System

Intervention Type DEVICE

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.

Group Type OTHER

LipiFlow Thermal Pulsation System

Intervention Type DEVICE

Treatment at 3 month visit as the cross-over group

Interventions

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LipiFlow Thermal Pulsation System

Treatment at preoperative visit for study group

Intervention Type DEVICE

LipiFlow Thermal Pulsation System

Treatment at 3 month visit as the cross-over group

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No