A randomised, controlled trial to evaluate corneal nerve function in healthy participants and in participants after laser in situ keratomileusis (LASIK) surgery

The University of Melbourne0 个研究点目标入组 29 人开始时间: 2023年8月2日最近更新: 2024年8月5日

适应症

试验速览

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•1.Written informed consent and documentation, in accordance with privacy requirements, obtained prior to performing any study procedures in the healthy and post-LASIK population;
•2.Ability to understand and follow study instructions, with the intention of completing all of the required study visits in the healthy and post-LASIK population;
•3.Distance best-corrected visual acuity of at least 6/9 Snellen equivalent in each eye using a standard visual acuity chart in the healthy and post-LASIK population;
•4.Post-LASIK population: participants who underwent LASIK, 6 months to 1 year prior to enrolment, for the correction of myopia;

•i) Healthy and post-LASIK population:
•1.Females who are currently pregnant or breastfeeding;
•2.Diagnosis of a systemic disease known to affect small nerve fibres or the health of the ocular surface;
•3.Current, or recent (within last 3 months), use of any agent (by any route of administration) known to substantially affect ocular surface health;
•4.Active ocular inflammation, allergy or infection;
•5.Any ocular surface condition or history of surgery that may adversely alter corneal nerves;
•6.Participants with a scheduled corneal surgery over the course of the study;
•7.Known allergy to, or previous reaction to, any agents required to be used for the study;
•8.History of chronic migraine
•ii).Healthy population: Clinically significant dry eye disease, as specified in the TFOS DEWS II definition;
•iii)Post-LASIK population: Post-LASIK ectasia; history of any surgery, other than a single LASIK surgery, that might affect the health of the ocular surface;

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