Contact Lens-induced Corneal Fluorescein Staining, Dry Eye, Dry Eye Syndromes
Conditions
Keywords
Dry Eye, Contact Lens, Corneal Staining, Tears, Comfort
Brief summary
This research assesses the tear performance of five distinct types of soft contact lenses commonly found in the market. The study involves contact lens participants, all of whom are students enrolled at UKM. Before the study, participants were instructed to discontinue wearing their usual contact lenses for two weeks. The lenses utilized in this clinical trial all possess current refractive power. Participants are required to wear the lenses for an entire day only. Upon completion of the study, participants will be requested to complete a brief questionnaire.
Detailed description
Before commencing the trial, all participants will undergo an anterior segment examination to ensure the eyes are in a healthy state, free from corneal diseases. Two parameters will be measured during this examination: Tear Break-Up Time (TBUT), which is a non-invasive method used to assess tear break-up, and the Schirmer Test, where a strip is placed on the lower eyelid for five minutes to evaluate tear wetting of the strip. The level of comfort after wearing contact lenses for 8 hours will be assessed using the Contact Lens Discomfort Index questionnaire. The sample size is determined using the formula by Daniel (1999). Ten percent of the total sample size represents the number of subjects for this study. Considering a dropout rate of 10%, this study requires 18 subjects.
Interventions
DEVICEEye Wearing Contact Lens
Each participant will be given 2 types of a different group of contact lenses for each eye and need to wear for 8 hours only. Measurements will be done pre and post wearing of lenses
Sponsors
National University of Malaysia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
The 6 types of Contact Lenses used will be labeled as A, B, C, D, E, and F by a co-investigator and will be fitted on the participant's eye randomly.
Intervention model description
18 participants will be fitted with 2 types of lenses on either eye at one time. There will be a 2-week wash-off period before another 2 set of fittings with another 4 types of lenses.
Eligibility
Sex/Gender
ALL
Age
19 Years to 29 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Volunteers * Age 19-29 years old * Refractive error is less than -6.00DS with astigmatism is less than -1.00DC * Have experience wearing Contact Lenses but agree to stop wearing them for 2 weeks before the study starts
Exclusion criteria
* smokers (Ward et al. 2010) * participants with ocular disease or trauma which includes Lasik patients and intra/extraocular surgery. * pregnant females (Yenerel & Kucumen 2015). * participants taking medication for systemic diseases (Fraunfelder et al. 2012).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess comfort level of participants using CL Discomfort Index Questionaire | 10 minutes | 8 questions to be answered for each lens |
| To assess the quantity of tears in eyes wearing contact lenses | 5 minutes | Schirmer Test is done on patients pre and post-wear. Results will be taken after 5 minutes of measurement using Schirmer Strips |
| To asess the quality of tears in eyes wearing contact lenses | 5 minutes | NIBUT is done on patients pre and post wear. (10 seconds) |
| To assess corneal staining in eyes wearing contact lenses | 5 minutes | Fluorescein in instill at the conjunctiva and staining is observed using cobalt blue light |
Countries
Malaysia
Contacts
Primary ContactMohd Norhafizun Mohd Saman, MSc
Backup ContactBashirah Ishak, PhD
Outcome results
None listed