Assessing corneal integrity in healthy eyes and eyes after laser refractive surgery
- Conditions
- Post-LASIKCorneal nerve functionEye - Diseases / disorders of the eyeEye - 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
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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method