LipiFlow for the treatment of dry eye disease.

BACKGROUND: Meibomian gland dysfunction (MGD) is the most common underlying cause of dry eye disease (DED). MGD leads to pathological alteration of the composition or quantity of meibum, or both, which subsequently results in tear evaporation and the typical signs and symptoms associated with DED. The LipiFlow Thermal Pulsation System (LipiFlow) is a medical device used to treat MGD in office; however, it is unclear if LipiFlow can outperform other DED treatments. OBJECTIVES: To evaluate the effectiveness of LipiFlow for treating DED signs and symptoms and the safety of LipiFlow compared with sham or other available treatments for MGD in adults. SEARCH METHODS: The Cochrane Eyes and Vision Information Specialist searched the electronic databases for randomized controlled trials. There were no restrictions on language or date of publication. We searched the Cochrane Central Register of Controlled Trials (CENTRAL, including the Cochrane Eyes and Vision Trials Register; 2022, Issue 6), MEDLINE Ovid, Embase.com, PubMed, LILACS (Latin American and Caribbean Health Science Information database), ClinicalTrials.gov, and World Health Organization International Clinical Trials Registry Platform (WHO ICTRP) electronic databases. We also examined the reference lists of identified trials, review articles, and guidelines for information about relevant trials that may not have been identified by our search strategy. We contacted investigators regarding ongoing trials. The last database search was performed on 24 October 2022. SELECTION CRITERIA: We included studies conducted in adults (over 18 years of age) with DED or MGD as defined by the primary trial investigators. We imposed no restrictions on race, ethnicity, or sex. We considered trials involving contact lens wearers if they were equally represented between groups. DATA COLLECTION AND ANALYSIS: We applied standard Cochrane methodology. MAIN RESULTS: We included 13 trials that randomized a total of 1155 participants (28 to 236 participants randomized per study). Six trials were conducted in the USA, three in China, two in Thailand, one in France, and one in Italy. Eight trials were of single-center design, while four trials were of multicenter design; one trial did not report the number of participating centers. Study characteristics The study population of the included trials was 66% female (range 48% to 80%), with an age range of 19 to 86 years. LipiFlow, used as a stand-alone intervention, was compared with basic warm compresses in five studies, thermostatic device in five studies, oral intervention in one trial, and topical dry eye medications in one trial. LipiFlow was also evaluated together with eyelid hygiene product versus eyelid hygiene products alone in one trial. Findings Five trials compared LipiFlow with a basic warm compress applied for varying durations and frequencies during the trial period; only one of these trials combined a warm compress with eyelid massage. Analyzing symptom scores by different questionnaires (Ocular Surface Disease Index [OSDI] and Standard Patient Evaluation of Eye Dryness [SPEED]) yielded conflicting evidence of a difference in symptoms between LipiFlow and basic warm compresses after four weeks. There was no evidence of a difference in meibomian gland expression, meibum quality, or tear breakup time when comparing LipiFlow with basic warm compresses. Another five trials compared LipiFlow with thermostatic devices. Analysis of symptom scores at four weeks showed that thermostatic devices had reduced OSDI scores by a mean difference (MD) of 4.59 (95% confidence interval [CI] 1.23 to 7.95; I2 = 0, P = 0.007; 553 participants; very low certainty evidence) as compared with LipiFlow. When we compared LipiFlow plus eyelid hygiene with eyelid hygiene alone, there was no evidence of difference in signs or symptoms at any time point evaluated. Only one trial compared LipiFlow with a topical DED medication (lifitegrast 5%). The single-trial estimate suggested that 5% lifitegrast may increase meibomian gland expression scores compared with LipiFlow at day 42 (MD -1.21, 95% CI -2.37 to -0.05; 50 participants; low certainty evidence) by using a meibomian gland expression scale of 0 to 8. One trial compared LipiFlow with an oral intervention (doxycycline), finding that LipiFlow may result in significantly better SPEED scores than doxycycline at three months (MD -4.00, 95% CI -7.33 to -0.67; 24 participants; very low certainty evidence). No other significant differences in signs or symptoms were found between LipiFlow and doxycycline at three months. We did not find any other statistically significant differences in symptoms or signs for any other analysis performed in this review at the one- to four-week time point. Adverse events No trial reported any intervention-related, vision-threatening adverse events. AUTHORS' CONCLUSIONS: LipiFlow performs similarly to other commonly used DED treatments with regard to DED signs and symptoms. The best available evidence was deemed to have a high level of bias, leading to low or very low certainty evidence. Additional research with adequate masking, a standardized testing methodology, and a sample representative of the MGD population is therefore needed before any firm conclusions can be drawn regarding comparative benefits and harms.

Vision Correction Habits After COVID-19 Onset in Spectacle and Contact Lens Wearers.

PURPOSE: To determine how vision correction habits changed after the 2019 coronavirus disease (COVID-19) pandemic onset. METHODS: Participants reported vision correction habits, refractive error, screen time, mask wearing time, and dry eye symptoms since the COVID-19 pandemic onset through email survey. RESULTS: A total of 133 participants completed the survey. Worsening dry eye symptoms were associated with increased screen time ( P =0.04). Hours per day of spectacle wear increased by approximately 1 hr ( P =0.001) and was associated with increased screen time ( P =0.002). Worsening dry eye symptoms were associated with increased days per week of spectacle wear ( P =0.02). Participants wore contact lenses about one day per week less than before the pandemic ( P =0.0001). Increased mask wearing time was associated with increased days per week of contact lens wear ( P =0.03). CONCLUSIONS: After pandemic onset, hours per day of spectacle wear increased, and days per week of contact lens wear decreased. Increases in hourly spectacle wear were associated with increased screen time, whereas increased daily contact lens wear was associated with increased mask wear time, suggesting that spectacles may be preferred for screen time activities and contact lenses for mask wear.

Visual discomfort and contact lens wear: A review.

The purpose of this manuscript is to describe how vision influences contact lens discomfort and review the evidence supporting the hypothesis that contact lens discomfort can be caused by vision and vision-related disorders. Contact lens discomfort is a misunderstood and difficult to manage clinical condition. Most treatments and strategies aimed at alleviating discomfort focus on optimizing the contact lens fit and its relationship with the ocular surface, but these strategies commonly fail at relieving discomfort symptoms. Many vision and vision-related disorders share symptoms with those reported by uncomfortable contact lens wearers. This paper will review evidence and literature that describes how these vision and vision-related disorders may influence comfort in contact lens wearers. Acknowledging how vision influences contact lens discomfort will improve future research intended to better understand the condition, allow for more effective clinical management, and reduce rates of discontinuation.

Impact of Mask-Associated Dry Eye on Symptom Score.

OBJECTIVES: Owing to widespread mask use during the COVID-19 pandemic and clinical reports tying mask use with dryness, this study endeavors to determine if mask use is linked to symptoms of dry eye. METHODS: A prospective, cross-sectional survey study was performed. The survey used a modified Standard Patient Evaluation of Eye Dryness Questionnaire (SPEED, TearScience, Morrisville, NC) within 15 min of the beginning and discontinuation of mask wear. The survey also asked about mask wear time, mask style, visual correction, age, and gender. RESULTS: The change in SPEED scores was statistically significant ( P =0.03) between participants with mild SPEED score at baseline (0-9) versus severe SPEED score at baseline (10-28) (n=77: 59 female, 16 male, 1 nonbinary, and 1 declined to answer; range 22-55 years old). Participants in the severe group used masks with nose wire more than the mild group ( P =0.03). CONCLUSIONS: In this sample, dry eye symptoms were most exacerbated with mask wear in those that had mild initial symptom scores compared with those with severe symptom scores at baseline. The use of nose wire masks may be protective, as the severe group used this type more and had significantly less exacerbation of symptoms postmask wear.

A review of meibomian gland structure, function, and contact lens wear.

PURPOSE: To provide a balanced literature review of the studies that have evaluated the effect of contact lenses on meibomian gland (MG) health. METHODS: A PubMed.gov literature search was conducted on or before May 15, 2021. No other time constraints were applied. Search terms included the following: "meibomian gland(s)" plus "contact lens(es)" or "meibography" plus "contact lens(es)". Only full text articles written in English were considered. The reference lists of recovered papers were used to identify articles missed during the primary search. Included articles were required to discuss the impact of contact lenses on MG morphology or function and were graded according to the level of evidence presented. RESULTS: The literature indicates that contact lenses impact MG function; however, the data are equivocal regarding contact lenses inducing MG structural changes. The literature likewise indicates that the mechanism(s) by which contact lenses impact the MGs are likely multifactorial. Recent data suggests that MGs may have some plasticity. Detected differences between studies likely stem from varied populations evaluated, study designs, and the duration of the evaluation periods. CONCLUSIONS: With this literature review finding conflicting relationships between MG health and contact lens use, future longitudinal studies with standardized clinical MG assessments are needed to determine the true impact of contact lenses on MG health. Until these data are obtained, contact lens wearers should undergo a full MG evaluation, especially because recent data suggest that MG treatments may restore MG structure and function.

Contact Lens Adaption in Neophytes.

SIGNIFICANCE: Clinicians commonly either recommend patients begin contact lens (CL) wear full time or suggest that patients should gradually increase their wear times during the first few days of wear. This study found no differences between these two wear schedules, suggesting that patient preference may be the best schedule. PURPOSE: The purpose of this study was to determine if there are any clinical differences in neophyte, 2-week, reusable soft CL wearers who were randomized to either a full-time or a gradually increasing wear time schedule. METHODS: This was an investigator-masked, three-visit, randomized, clinical trial. Participants were randomized to wear their CLs full time starting on the first day or gradually starting with 2 hours of wear on the first day and increasing wear by 2 hours each day until 8 hours or more of wear per day was achieved. Symptoms (Ocular Surface Disease Index and visual analog scale) and ocular surface signs (tear breakup time, extent of corneal staining, and Schirmer test I) were evaluated at each visit. RESULTS: A total of 25 participants were randomized, with 21 participants completing at least 1 week of follow-up. Completed participants had a mean ± standard deviation age of 23.5 ± 3.0 years, and 48% were female. No significant between-group differences were found when comparing the full-time and gradual wear time schedule groups at 2 weeks (all, P > .32): Ocular Surface Disease Index (10.8 ± 8.5 vs. 16.3 ± 18.8), visual analog scale (89.0 ± 9.7 vs. 81.8 ± 18.7), tear breakup time (11.7 ± 7.0 vs. 9.8 ± 2.7), extent of corneal staining (0.0 ± 0.1 vs. 0.3 ± 0.5), or Schirmer test I (15.9 ± 8.8 vs. 21.2 ± 12.5). CONCLUSIONS: No between-group differences were found for any metric evaluated, which suggests that the best wear schedule may be the one that best suits the neophyte CL wearer's lifestyle.

A randomised clinical trial of multifocal contact lenses and contact lens discomfort.

PURPOSE: To determine how multifocal contact lenses affect contact lens discomfort. METHODS: This randomised, participant-masked, crossover clinical trial fitted 84 uncomfortable soft contact lens wearers (30-40 years old) with single vision and multifocal contact lenses. Contact lens discomfort was assessed using the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8). RESULTS: There was no difference between multifocal and single vision survey scores (p = 0.08). There was an interaction between lens type and age group (p = 0.05). CLDEQ-8 scores with the single vision lens were less symptomatic than multifocal scores in participants <35 years old (p = 0.01). Single vision and multifocal scores for the older age group were not different. Subjectively, those in the <35 year-old age group preferred the single vision lens for intermediate (p = 0.02), distance (p = 0.003), and overall vision (p = 0.002). In the ≥35 year-old age group, no lens was significantly preferred for vision. CONCLUSIONS: Participants in the younger age group had more favourable wearing experiences with the single vision lens compared to the multifocal lens. The older age group, however, had similar wearing experiences with both lens types. While younger contact lens wearers may prefer the wearing experience with single vision lenses, some uncomfortable contact lens wearers approaching 40 years old may benefit from wearing a multifocal contact lens sooner in life than is typically practised.

A study of contact lens compliance in a non-clinical setting.

PURPOSE: To evaluate soft contact lens replacement, overnight (ON) wear, and contact lens case compliance in a non-clinical sample. METHODS: Subjects (n = 297) were recruited at the Center for Science and Industry (COSI) in Columbus, Ohio. Adult (≥ 18 years) soft contact lens wearers completed a survey about contact lens replacement, ON contact lens wear, and contact lens case replacement habits. RESULTS: Two-week replacement lenses (according to the manufacturer's replacement schedule [MRS]) were most common (45.5%), followed by monthly (34.3%) and daily replacement (20.2%). Non-compliance with replacement schedule was reported in 38.7% of subjects. Age (p = 0.02), years of lens wear (p = 0.02), and MRS (p <0.0001) affected replacement compliance. Post-hoc analysis showed daily replacement wearers were more compliant than two-week (p <0.0001) and monthly (p <0.0001) replacement wearers with prescribed lens replacement. Non-compliance with prescribed ON wear was reported in 23.9% of subjects. Subjects who were non-compliant with lens replacement were more likely to be non-compliant with ON wear (p = 0.02) and had worn contact lenses for less time (p = 0.02). Of the subjects who used contact lens cases, 74.6% were unsure when they should replace their case. Frequency of case replacement was not associated with age (p = 0.5), gender (p = 0.5), years of contact lens wear (p = 0.7), MRS (p = 0.4), replacement compliance (p = 0.3), or ON wear compliance (p = 0.7). CONCLUSIONS: Daily replacement wearers were most likely to be compliant with contact lens replacement, but all subjects, including daily replacement wearers, had similar ON wear non-compliance. Non-compliant lens replacement was associated with non-compliant ON wear, but contact lens case replacement was not related to either compliance category. The majority of subjects had no knowledge of proper contact lens case replacement, despite compliance in other categories.

Presbyopic and non-presbyopic contact lens opinions and vision correction preferences.

PURPOSE: To compare vision correction preferences, refractive error, and gender of non-presbyopes and presbyopes. METHODS: Adults who wear spectacles or contact lenses completed a survey about refractive correction opinions and refractive error was measured. RESULTS: Of the 304 subjects, 38.2% were presbyopic (≥40 years) and 59.2% were female. Spectacles were the primary vision correction for 78.0% of subjects. Compared to contact lens wearers, the proportion of presbyopes was higher (p=0.006) in spectacle wearers. There was no difference in the proportion of presbyopes and non-presbyopes who have tried contact lenses (p=0.2) or who would prefer to wear contact lenses (p=0.2). In contact lens wearers, there was no difference in the proportion of presbyopes and non-presbyopes with a history of temporary discontinuation (p=0.9). Within the contact lens wearing group, there was no refractive error difference between presbyopes and non-presbyopes (spherical equivalent p=0.6; power vector J0 p=0.5; power vector J45 p=0.4; anisometropia p=0.2). Overall, contact lens wearers were more likely to be female (p=0.004). There was no difference in gender in presbyopic and non-presbyopic contact lens wearers (p=0.5). CONCLUSIONS: Presbyopes and non-presbyopes have similar opinions about spectacles and contact lenses. Presbyopes of all refractive errors prefer contact lens correction when good vision and comfort can be achieved. Eye care providers should not assume that presbyopia, refractive error, or gender are factors that preclude a patient from being interested in contact lens wear.

A Survey of Presbyopic Contact Lens Wearers in a University Setting.

PURPOSE: To determine why presbyopic patients discontinue contact lens wear and describe their opinions of comfort and visual quality with contact lenses. METHODS: A survey assessing current age, gender, contact lens material/design, and opinions of contact lens comfort and visual quality was mailed to 2400 presbyopic patients (age 40 years and older) that have had eye exams in the Ohio State University College of Optometry's Contact Lens Services over the last 4 years. RESULTS: A total of 496 surveys were analyzed. The mean age of survey respondents was 57 ± 9 years, and 68% of the sample was female. Permanent discontinuation of contact lens wear was reported by 15%. No association was found between contact lens discontinuation and age (p = 0.7), gender (p = 0.2), age of beginning contact lens wear (p = 0.1), or contact lens material (p = 0.1). Poor vision (38%), discomfort (34%), convenience (20%), and cost (6%) were the primary reported reasons for discontinuation. There was no difference between the proportion of subjects reporting "poor vision" as their primary discontinuation reason and those reporting "discomfort" (p = 0.7). Discontinued wearers had a worse overall opinion of their distance (p = 0.03), intermediate (p = 0.01), and near vision (p = 0.002) compared to subjects who were still wearing their contact lenses. CONCLUSIONS: Discomfort has been reported as the primary reason for contact lens discontinuation. In this presbyopic population, dissatisfaction with vision and discomfort were reported equally as often as primary reasons for discontinuation. As well, subjects who ceased contact lens wear had worse overall opinions of their vision at all distances than current contact lens wearers. The results of this survey suggest that presbyopes have unique demands and opinions related to contact lens wear.

Contact lens associated microbial keratitis: practical considerations for the optometrist.

Microbial keratitis (MK) is a corneal condition that encompasses several different pathogens and etiologies. While contact lens associated MK is most often associated with bacterial infections, other pathogens (fungi, Acanthamoeba species, etc) may be responsible. This review summarizes the risk factors, microbiology, diagnostic characteristics, and treatment options for all forms of contact lens-related MK.

Can Binocular Vision Disorders Contribute to Contact Lens Discomfort?

PURPOSE: To determine the relationship between binocular vision (BV) disorder and dry eye symptoms and the frequency of BV disorders in subjects with contact lens-induced dry eye symptoms. METHODS: Subjects recruited for a larger dry eye study (n = 104) completed the Ocular Surface Disease Index (OSDI) and Convergence Insufficiency Symptom Survey (CISS) to determine if symptoms assessed on these two surveys were related. Also, myopic soft contact lens wearers (n = 29) with self-reported dry eye symptoms were recruited. Subjects completed the OSDI and CISS to assess severity of dry eye and BV disorder symptoms. Basic BV and dry eye testing was performed on each subject. RESULTS: Severity of symptoms assessed on the OSDI and CISS was found to be significantly correlated in the larger subject group (ρ = 0.68, p = 0.0001). This significant correlation warranted further investigation of both symptoms and clinical signs. In the group of myopic soft contact lens wearers, 48.3% had a BV disorder. This proportion appeared to be higher than previously reported prevalence estimates of BV disorders. Accommodative lag greater than or equal to 1.00 diopter was the most common BV disorder sign encountered (48.3%), and pseudo-convergence insufficiency was the most common BV disorder (31.0%). CONCLUSIONS: Symptoms related to dry eye and BV disorders overlap. Subjects with symptoms of discomfort while wearing soft contact lenses may be experiencing a concurrent or stand-alone BV disorder. Accommodative insufficiency and pseudo-convergence insufficiency were common in the sample of myopic soft contact lens wearers. Clinicians should screen symptomatic contact lens-induced dry eye patients for BV disorders. Dry eye studies should assess basic BV function.