MedPath

Assessing corneal integrity in healthy eyes and eyes after laser refractive surgery

Not Applicable
Active, not recruiting
Conditions
Post-LASIK
Corneal nerve function
Eye - Diseases / disorders of the eye
Eye - Normal eye development and function
Registration Number
ACTRN12623000830695
Lead Sponsor
The University of Melbourne
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Active, not recruiting
Sex
All
Target Recruitment
29
Inclusion Criteria

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;

Exclusion Criteria

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;

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath