Cataracts, Meibomian Gland Dysfunction (MGD)
Conditions
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.
Interventions
Treatment at preoperative visit for study group
Sponsors
Johnson & Johnson Surgical Vision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Monocular UCDVA (Uncorrected Distance Visual Acuity) | 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 | 2-4 weeks after first Pre-operative visit | Biometry testing was done pre-operatively |
| Precision of Axial Length (AL) and Anterior Chamber Depth (ACD) | 2-4 weeks after first Pre-operative visit | Biometry testing was done pre-operatively |
| Rate of Refractive Predictability | 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 | 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 | 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). |
Countries
United States
Participant flow
Pre-assignment details
All study subjects enrolled from the normal surgical cataract population with bilateral mild to moderate Meibomian Gland Dysfunction, scheduled for bilateral cataract surgeries with Symfony Intraocular Lens implantation, at 5 sites in the U.S.A. 143 Subjects were consented, 26 screen-failed and 117 were randomized and bilaterally implanted. 115 evaluable subjects completed the study (58 in the study group and 57 in the Control Group).
Participants by arm
| Arm | Count |
|---|---|
| Study Group LipiFlow treatment at Pre-operative | 59 |
| Study Group LipiFlow treatment at Pre-operative | 117 |
| Control Group LipiFlow treatment following 3-month visit | 58 |
| Control Group LipiFlow treatment following 3-month visit | 115 |
| Total | 349 |
Baseline characteristics
| Characteristic | Study Group | Control Group | Total |
|---|---|---|---|
| Age, Customized 30-39 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Customized 40-49 years | 1 Participants | 1 Participants | 2 Participants |
| Age, Customized 50-59 years | 13 Participants | 10 Participants | 23 Participants |
| Age, Customized 60-69 years | 28 Participants | 31 Participants | 59 Participants |
| Age, Customized >=70 years | 16 Participants | 16 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 57 Participants | 55 Participants | 112 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian (Including Indian) | 3 Participants | 4 Participants | 7 Participants |
| Race/Ethnicity, Customized Black | 8 Participants | 12 Participants | 20 Participants |
| Race/Ethnicity, Customized Caucasian | 48 Participants | 42 Participants | 90 Participants |
| Sex: Female, Male Female | 34 Participants | 35 Participants | 69 Participants |
| Sex: Female, Male Male | 25 Participants | 23 Participants | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 59 | 0 / 58 | 0 / 56 |
| other Total, other adverse events | 0 / 59 | 2 / 58 | 5 / 56 |
| serious Total, serious adverse events | 3 / 59 | 4 / 58 | 1 / 56 |
Outcome results
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).
Time frame: Preoperative Visit (Baseline) and Postoperative Visit between 30-60 days after cataract surgery on the second eye.
Population: Results from both eyes from all randomized subjects were included. Not all subjects completed all tests.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group | Mean Change in Total Meibomian Gland Score From Baseline to 1 Month Postoperative | 4.8 Units on a scale | Standard Deviation 8.2 |
| Control Group | Mean Change in Total Meibomian Gland Score From Baseline to 1 Month Postoperative | 3.9 Units on a scale | Standard Deviation 8.3 |
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).
Time frame: 3 months Postoperative
Population: Results from both eyes from all randomized subjects were included. Not all subjects completed all tests.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Group | Mean Monocular UCDVA (Uncorrected Distance Visual Acuity) | 0.08 LogMAR | Standard Deviation 0.15 |
| Control Group | Mean Monocular UCDVA (Uncorrected Distance Visual Acuity) | 0.07 LogMAR | Standard Deviation 0.13 |
Primary
Precision of Axial Length (AL) and Anterior Chamber Depth (ACD)
Biometry testing was done pre-operatively
Time frame: 2-4 weeks after first Pre-operative visit
Population: Results from both eyes from all randomized subjects were included. Not all subjects completed all tests.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Group | Precision of Axial Length (AL) and Anterior Chamber Depth (ACD) | Precision of Axial Length (AL) | 0.0 mm | Standard Deviation 0.02 |
| Study Group | Precision of Axial Length (AL) and Anterior Chamber Depth (ACD) | Precision of Anterior Chamber Depth (ACD) | 0.0 mm | Standard Deviation 0.01 |
| Control Group | Precision of Axial Length (AL) and Anterior Chamber Depth (ACD) | Precision of Anterior Chamber Depth (ACD) | 0.0 mm | Standard Deviation 0.02 |
| Control Group | Precision of Axial Length (AL) and Anterior Chamber Depth (ACD) | Precision of Axial Length (AL) | 0.0 mm | Standard Deviation 0.01 |
Primary
Precision (Standard Deviation) of Preoperative Keratometric Measurements
Biometry testing was done pre-operatively
Time frame: 2-4 weeks after first Pre-operative visit
Population: Results from both eyes from all randomized subjects were included. Not all subjects completed all tests.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Group | Precision (Standard Deviation) of Preoperative Keratometric Measurements | Precision of Keratometry 1 (K1) | 0.0 diopter | Standard Deviation 0.09 |
| Study Group | Precision (Standard Deviation) of Preoperative Keratometric Measurements | Precision of Keratometry 2 (K2) | 0.0 diopter | Standard Deviation 0.09 |
| Control Group | Precision (Standard Deviation) of Preoperative Keratometric Measurements | Precision of Keratometry 1 (K1) | -0.01 diopter | Standard Deviation 0.07 |
| Control Group | Precision (Standard Deviation) of Preoperative Keratometric Measurements | Precision of Keratometry 2 (K2) | 0.0 diopter | Standard Deviation 0.07 |
Primary
Rate of Bothersome Ocular Symptoms
Patient-Reported Visual Symptom Questionnaire (PRVSQ) Rating Results at 3 months postoperative
Time frame: 3 months postoperative
Population: Questionnaires were completed by bilaterally implanted participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Rate of Bothersome Ocular Symptoms | Q3a) Multiple or Double vision over the last 7 days | 15 Participants |
| Study Group | Rate of Bothersome Ocular Symptoms | Q5a) Glare related to scattered light over the last 7 days | 20 Participants |
| Study Group | Rate of Bothersome Ocular Symptoms | Q2a) Starburst over the last 7 days | 36 Participants |
| Study Group | Rate of Bothersome Ocular Symptoms | Q6a) Occlusions over the last 7 days | 1 Participants |
| Study Group | Rate of Bothersome Ocular Symptoms | Q4a) Sensitivity to Light over the last 7 days | 38 Participants |
| Study Group | Rate of Bothersome Ocular Symptoms | Q7a) Poor Low Light Vision over the last 7 days | 36 Participants |
| Study Group | Rate of Bothersome Ocular Symptoms | Q1a) Halos over the last 7 days | 34 Participants |
| Control Group | Rate of Bothersome Ocular Symptoms | Q7a) Poor Low Light Vision over the last 7 days | 33 Participants |
| Control Group | Rate of Bothersome Ocular Symptoms | Q1a) Halos over the last 7 days | 45 Participants |
| Control Group | Rate of Bothersome Ocular Symptoms | Q2a) Starburst over the last 7 days | 40 Participants |
| Control Group | Rate of Bothersome Ocular Symptoms | Q3a) Multiple or Double vision over the last 7 days | 5 Participants |
| Control Group | Rate of Bothersome Ocular Symptoms | Q4a) Sensitivity to Light over the last 7 days | 33 Participants |
| Control Group | Rate of Bothersome Ocular Symptoms | Q5a) Glare related to scattered light over the last 7 days | 28 Participants |
| Control Group | Rate of Bothersome Ocular Symptoms | Q6a) Occlusions over the last 7 days | 2 Participants |
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.
Time frame: Difference between Baseline visit and Postoperative visit at 10-14 weeks after cataract surgery on the second eye.
Population: Results from both eyes from all randomized subjects were included. Not all subjects completed all tests.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Study Group | Rate of Refractive Predictability | +/- 0.50 D | 73.3 Percentage of eyes |
| Study Group | Rate of Refractive Predictability | +/- 1.00 D | 94.0 Percentage of eyes |
| Control Group | Rate of Refractive Predictability | +/- 0.50 D | 82.5 Percentage of eyes |
| Control Group | Rate of Refractive Predictability | +/- 1.00 D | 98.2 Percentage of eyes |