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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eye wearing contact lens | Experimental | The participant will be given two contact lenses (Lens A and B) to be placed on each eye. This phase will be repeated with C &D and lens E & F at different times. Each phase will have a 2 weeks wash-off period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eye Wearing Contact Lens | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the quantity of tears in eyes wearing contact lenses | Schirmer Test is done on patients pre and post-wear. Results will be taken after 5 minutes of measurement using Schirmer Strips | 5 minutes |
| To asess the quality of tears in eyes wearing contact lenses | NIBUT is done on patients pre and post wear. (10 seconds) | 5 minutes |
| To assess corneal staining in eyes wearing contact lenses | Fluorescein in instill at the conjunctiva and staining is observed using cobalt blue light | 5 minutes |
| To assess comfort level of participants using CL Discomfort Index Questionaire | 8 questions to be answered for each lens | 10 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohd Norhafizun Mohd Saman, MSc | Contact | 0122431452 | hafizunsaman@ukm.edu.my | |
| Bashirah Ishak, PhD | Contact | 0133889963 | bashirah@ukm.edu.my |
| Name | Affiliation | Role |
|---|---|---|
| Haliza Abdul Mutalib, PhD | National University of Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Optometry Clinic | Kuala Lumpur | 50300 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27830209 | Background | Asharlous A, Jafarzadehpur E, Mirzajani A, Khabazkhoob M, Heydarian S, Taghipour A. Tear Deformation Time and optical quality in eyes wearing silicone hydrogel contact lenses. J Curr Ophthalmol. 2016 Jul 25;28(4):226-227. doi: 10.1016/j.joco.2016.07.002. eCollection 2016 Dec. | |
| 18997539 | Background | Brautaset RL, Nilsson M, Leach N, Miller WL, Gire A, Quintero S, Bergmanson JP. Corneal and conjunctival epithelial staining in hydrogel contact lens wearers. Eye Contact Lens. 2008 Nov;34(6):312-6. doi: 10.1097/ICL.0b013e3181891439. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 2, 2024 | Apr 1, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D022125 | Lacerations |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D014947 | Wounds and Injuries |
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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.
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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.
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| 33735595 | Result | Arroyo-Del Arroyo C, Fernandez I, Lopez-de la Rosa A, Pinto-Fraga J, Gonzalez-Garcia MJ, Lopez-Miguel A. Design of a questionnaire for detecting contact lens discomfort: the Contact Lens Discomfort Index. Clin Exp Optom. 2022 Apr;105(3):268-274. doi: 10.1080/08164622.2021.1896945. Epub 2021 Mar 18. |