CataractsNCT03708367
A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice
A study testing LipiFlow Thermal Pulsation System in people with Cataracts and Meibomian Gland Dysfunction (MGD), run by Johnson & Johnson Surgical Vision, Inc. at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Cataracts, Meibomian Gland Dysfunction (MGD)
- What is being tested?
- LipiFlow Thermal Pulsation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 5 sitesUnited States
- Study dates
- 16 Oct 2018to 13 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 28Show fewer
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Empire Eye & Laser Center, Inc.
Bakersfield, California, 93309
Eye Doctors of Washington
Chevy Chase, Maryland, 20815
JW Eye Associates, P.A.
Dallas, Texas, 75243
Texas Eye & Laser Center, P.A.
Hurst, Texas, 76054
Matossian Eye Associates
Pennington, New Jersey, 08534
About this study
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)
- Being tested
- LipiFlow Thermal Pulsation System
- Medical subject headings
- Cataract, Meibomian Gland Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LipiFlow Thermal Pulsation SystemDevice
Treatment at preoperative visit for study group
LipiFlow Thermal Pulsation SystemDevice
Treatment at 3 month visit as the cross-over group
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: LipiFlow Thermal Pulsation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months Postoperative
Precision (Standard Deviation) of Preoperative Keratometric Measurements
Biometry testing was done pre-operatively
Measured: 2-4 weeks after first Pre-operative visit
Precision of Axial Length (AL) and Anterior Chamber Depth (ACD)
Biometry testing was done pre-operatively
Measured: 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.
Measured: 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
Measured: 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).
Measured: Preoperative Visit (Baseline) and Postoperative Visit between 30-60 days after cataract surgery on the second eye.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start16 Oct 2018
- Primary completion13 Jan 2020
- Study completion13 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Priya Janakiraman, OD, Study director, Johnson & Johnson Surgical Vision, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708367
- Sponsor's protocol ID
- DRYE-102-SELF
- Status last verified
- Mar 2021
- First submitted
- 8 Oct 2018
- Last updated
- 27 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 37318707
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Evaluation of LipiFlow Treatment in Cataract Surgery Practice
- ClinicalTrials.gov ID
- NCT03708367
- Acronym / sponsor ID
- DRYE-102-SELF
- Conditions
- Cataracts, Meibomian Gland Dysfunction (MGD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Johnson & Johnson Surgical Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 13 Jan 2020 (actual)
- Study completion
- 13 Jan 2020 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Posted 27 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group: LipiFlow Treatment at PreOp | Experimental | Device: LipiFlow Thermal Pulsation SystemStudy 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 |
| Control Group | Other | Device: LipiFlow Thermal Pulsation SystemStudy 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LipiFlow Thermal Pulsation SystemTreatment at preoperative visit for study group | Device | Study Group: LipiFlow Treatment at PreOp |
| LipiFlow Thermal Pulsation SystemTreatment at 3 month visit as the cross-over group | Device | Control Group |
Primary outcome
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37318707Matossian 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Priya Janakiraman, OD study director
Johnson & Johnson Surgical Vision, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LipiFlow Thermal Pulsation System in people with Cataracts and Meibomian Gland Dysfunction (MGD), run by Johnson & Johnson Surgical Vision, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Monocular UCDVA (Uncorrected Distance Visual Acuity) (time frame: 3 months Postoperative). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03708367, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.