Dataset Information

Therapeutic HL-Contact Lens versus Standard Bandage Contact Lens for Corneal Edema: A Prospective, Multicenter, Randomized, Crossover Study.

ABSTRACT: Introduction:To compare the safety and efficacy of the Therapeutic Hyper-CL™ lens versus a standard bandage contact lens (PureVision B&L) for chronic corneal edema. Methods:Prospective, multicenter, randomized, crossover study. Chronic corneal edema patients were randomized to one of two arms. The first arm was fitted with the Therapeutic Hyper-CL™ lens while the second arm was fitted with a standard soft bandage contact lens. Both arms were treated with 5% sodium chloride 6 times a day. After a 7-day treatment period, there was a 7-day washout period, after which the arms were crossed over. Patients were evaluated at days 0 (baseline), 7 (following first treatment allocation), 14 (following washout), and 21 (following second treatment allocation). The primary outcomes were 3 lines of BCVA (best corrected visual acuity) improvement. Results:In total, 49 patients were enrolled. There was significantly greater BCVA improvement rate >3 lines (30.4% versus 17.4%, P=0.04) in the Therapeutic Hyper-CL™ lens group. The mean change in BCVA lines was significantly greater for the Therapeutic Hyper-CL™ lens (3.4?±?6.7 versus 0.9?±?2.3, P=0.02). Conclusions:The Therapeutic Hyper-CL™ lens was associated with a higher chance for significant visual acuity improvement when compared to a standard bandage contact lens combined with 5% sodium chloride. This trial is registered with NCT02660151.

SUBMITTER: Daphna O

PROVIDER: S-EPMC7525312 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Therapeutic HL-Contact Lens versus Standard Bandage Contact Lens for Corneal Edema: A Prospective, Multicenter, Randomized, Crossover Study.

Daphna Ofer O Mimouni Michael M Keshet Yariv Y Ben Ishai Meydan M Barequet Irina S IS Knyazer Boris B Mrukwa-Kominek Ewa E Zarnowski Tomasz T Chen-Zion Malca M Marcovich Arie A

Journal of ophthalmology 20200921

<h4>Introduction</h4>To compare the safety and efficacy of the Therapeutic Hyper-CL™ lens versus a standard bandage contact lens (PureVision B&L) for chronic corneal edema.<h4>Methods</h4>Prospective, multicenter, randomized, crossover study. Chronic corneal edema patients were randomized to one of two arms. The first arm was fitted with the Therapeutic Hyper-CL™ lens while the second arm was fitted with a standard soft bandage contact lens. Both arms were treated with 5% sodium chloride 6 times ...[more]

PMID: 33014443

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Project description:Contact lenses represent a widely utilized form of vision correction with more than 140 million wearers worldwide. Although generally well-tolerated, contact lenses can cause corneal infection (microbial keratitis), with an approximate annualized incidence ranging from ~2 to ~20 cases per 10,000 wearers, and sometimes resulting in permanent vision loss. Research suggests that the pathogenesis of contact lens-associated microbial keratitis is complex and multifactorial, likely requiring multiple conspiring factors that compromise the intrinsic resistance of a healthy cornea to infection. Here, we outline our perspective of the mechanisms by which contact lens wear sometimes renders the cornea susceptible to infection, focusing primarily on our own research efforts during the past three decades. This has included studies of host factors underlying the constitutive barrier function of the healthy cornea, its response to bacterial challenge when intrinsic resistance is not compromised, pathogen virulence mechanisms, and the effects of contact lens wear that alter the outcome of host-microbe interactions. For almost all of this work, we have utilized the bacterium Pseudomonas aeruginosa because it is the leading cause of lens-related microbial keratitis. While not yet common among corneal isolates, clinical isolates of P. aeruginosa have emerged that are resistant to virtually all currently available antibiotics, leading the United States CDC (Centers for Disease Control) to add P. aeruginosa to its list of most serious threats. Compounding this concern, the development of advanced contact lenses for biosensing and augmented reality, together with the escalating incidence of myopia, could portent an epidemic of vision-threatening corneal infections in the future. Thankfully, technological advances in genomics, proteomics, metabolomics and imaging combined with emerging models of contact lens-associated P. aeruginosa infection hold promise for solving the problem - and possibly life-threatening infections impacting other tissues.

Project description:PurposeTo assess the efficacy of applying bandage contact lens (BCL) in reducing the fibrotic healing response of flap margins following femtosecond laser in situ keratomileusis (FS-LASIK).MethodsIn this prospective, randomized, interventional, observer-masked trial, 41 patients (82 eyes) with myopia and/or myopic astigmatism were scheduled to undergo FS-LASIK. After surgery, patients were fitted with a BCL in one eye (BCL eyes, n=41) but not in the contralateral eye (control eyes, n=41), following randomized allocation of the BCL to the left or right eye of each patient. The BCL was left in place overnight and removed the following morning. All eyes subsequently received standardized postoperative treatments. Patients were followed up for 6 months. We evaluated patients' self-reported postoperative symptom scores for pain, photophobia, tearing, and foreign-body sensation. At 6 months after surgery, we examined the corneal flap margin and adjacent regions, and photographed them using slit-lamp biomicroscopy, to subjectively evaluate the wound healing response.ResultsPostoperative pain and photophobia were milder in the BCL group than in the control group (P=0.041 and P=0.003, respectively), but patients felt more foreign-body sensation in the eye with a BCL than in the control eye (P=0.001). There was no significant difference in tearing score between BCL eyes and control eyes (P=0.118). Regarding the fibrotic healing response of the flap margin, control eyes showed a wide, bright peripheral circumferential band with a spiculated edge and high reflectivity; conversely, BCL eyes showed a markedly narrower and smoother peripheral circumferential band, with a less spiculated edge and lower reflectivity (P < 0.001).ConclusionPatients felt less discomfort in eyes treated with a BCL after FS-LASIK than in control eyes. BCL-treated eyes also had a less intense wound healing response at the flap margins than control eyes in some of patients. BCLs may merit consideration as a treatment option after FS-LASIK for special patients. This trial is registered with ChiCTR1800016579.

Dataset Information

Therapeutic HL-Contact Lens versus Standard Bandage Contact Lens for Corneal Edema: A Prospective, Multicenter, Randomized, Crossover Study.

Publications

Therapeutic HL-Contact Lens versus Standard Bandage Contact Lens for Corneal Edema: A Prospective, Multicenter, Randomized, Crossover Study.

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