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INTRODUCTION: Patients implanted with a range-of-vision intraocular lens (IOL) (multifocal or extended depth of focus, EDOF) may be more susceptible to visual disturbances from poor tear film quality, and prophylactic treatment of meibomian gland dysfunction (MGD) has been recommended. The purpose was to evaluate whether vectored thermal pulsation (LipiFlow™) treatment prior to cataract surgery with a range-of-vision IOL safely improves postoperative outcomes. METHODS: This is a prospective, randomized, open-label, crossover, multicenter study of patients with mild-to-moderate MGD and cataract. The test group underwent LipiFlow treatment prior to cataract surgery and implantation of an EDOF IOL, while the control group did not. Both groups were evaluated 3 months postoperatively, after which the control group received LipiFlow treatment (crossover). The control group was re-evaluated 4 months postoperatively. RESULTS: A total of 121 subjects were randomized, with 117 eyes in the test group and 115 eyes in the control group. At 3 months after surgery, the test group had a significantly greater improvement from baseline in total meibomian gland score compared with the control group (P = 0.046). At 1 month after surgery, the test group had a significant decrease in corneal (P = 0.04) and conjunctival (P = 0.002) staining compared to the control group. At 3 months after surgery, the test group had significantly lower incidence of being bothered by halos compared with the control group (P = 0.019). The control group had a significantly lower incidence of being bothered by multiple or double vision compared with the test group (P = 0.016). After crossover, patients had significant improvement in vision (P = 0.03) and total meibomian gland score (P < 0.0001). No safety concerns or relevant safety findings were uncovered. CONCLUSION: Presurgical LipiFlow treatment of patients implanted with range-of-vision IOLs improved meibomian gland function and postoperative ocular surface health. This supports guidelines recommending proactive diagnosis and management of MGD in patients with cataracts to improve patient experience. TRIAL REGISTRATION: The study was registered on www. CLINICALTRIALS: gov (NCT03708367).
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PURPOSE: To investigate which warm compress (WC) methods used in a small case series are the most effective in providing heat to the inner eyelids for the supplemental treatment of meibomian gland dysfunction. METHODS: Inclusion criteria included the following: 18 years or older and willingness to participate in the study, no current ocular inflammation/disease, and no ocular surgery within the last 6 months. Five patients were fully consented and enrolled. Various forms of contact and noncontact WC heating methods (dry, wet/moist, and chemically activated dry heat) were tested. A paired contralateral design was used; each subject had a heated test eye and an unheated control eye. For both test and control eyes, the temperature of the external upper, external lower, and internal lower lids was measured at baseline and every 2 minutes for 10 minutes during application. Each participant underwent each of the eight treatments under study. Microwaved compresses were heated to 47 ± 1.0°C; two compresses were self-heating and thus not under investigator control. RESULTS: The mean (± SD) age of the patients was 42.2 (± 20.3) years. Out of the eight methods tested, the bundled wet/moist towel method was the only compress that elevated the temperature of all three lid surfaces (external upper, external lower, and internal lower lids) to 40°C or higher. The chemically activated EyeGiene, MGDRx EyeBag, and MediBeads compresses resulted in the lowest temperature increase at the inner palpebral surface. CONCLUSIONS: The Bundle method, although the most labor intensive, increased lid temperatures above therapeutic levels, as reported in the literature, for all measured sections during the WC application. As such, this method of WC application can be recommended for supplemental at-home therapy for meibomian gland dysfunction and any condition requiring that therapeutic heat of 40°C be administered to the meibomian glands.