A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03708367 |
Recruitment Status :
Completed
First Posted : October 17, 2018
Results First Posted : April 27, 2021
Last Update Posted : April 27, 2021
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cataracts Meibomian Gland Dysfunction (MGD) | Device: LipiFlow Thermal Pulsation System | Not Applicable |
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 |
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 |
- 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).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 22 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03708367
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 |
Study Director: | Priya Janakiraman, OD | Johnson & Johnson Surgical Vision, Inc. |
Documents provided by Johnson & Johnson Surgical Vision, Inc.:
Responsible Party: | Johnson & Johnson Surgical Vision, Inc. |
ClinicalTrials.gov Identifier: | NCT03708367 |
Other Study ID Numbers: |
DRYE-102-SELF |
First Posted: | October 17, 2018 Key Record Dates |
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 |
Cataract Meibomian Gland Dysfunction Lens Diseases Eye Diseases Eyelid Diseases |