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

Cataracts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03708367
• Other study ID #: DRYE-102-SELF
• Status: Completed
• Phase: N/A
• Start date: October 16, 2018
• Est. completion date: January 13, 2020

Study information

• Verified date: March 2021
• Source: Johnson & Johnson Surgical Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: January 13, 2020
• Est. primary completion date: January 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Cataracts
• Meibomian Gland Dysfunction (MGD)

Intervention

Device:
• LipiFlow Thermal Pulsation System
Treatment at preoperative visit for study group
• LipiFlow Thermal Pulsation System
Treatment at 3 month visit as the cross-over group

Locations

Country	Name	City	State
United States	Empire Eye & Laser Center, Inc.	Bakersfield	California
United States	Eye Doctors of Washington	Chevy Chase	Maryland
United States	JW Eye Associates, P.A.	Dallas	Texas
United States	Texas Eye & Laser Center, P.A.	Hurst	Texas
United States	Matossian Eye Associates	Pennington	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Surgical Vision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Precision (Standard Deviation) of Preoperative Keratometric Measurements	Biometry testing was done pre-operatively	2-4 weeks after first Pre-operative visit
Primary	Precision of Axial Length (AL) and Anterior Chamber Depth (ACD)	Biometry testing was done pre-operatively	2-4 weeks after first Pre-operative visit
Primary	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.
Primary	Rate of Bothersome Ocular Symptoms	Patient-Reported Visual Symptom Questionnaire (PRVSQ) Rating Results at 3 months postoperative	3 months postoperative
Primary	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.