Dry Eye Disease Clinical Trial
Official title:
A Single Center,Randomized,Controlled Trial Assessing the Effects of Spectacles or Orthokeratology on Dry Eye Parameters in Children and Adolescents.
Orthokeratology(OK) is currently one of the effective methods for treating myopia, reshaping the corneal epithelium to change refractive power. Due to its contact with the ocular surface, long-term wearing could lead to symptoms and signs of dry eye disease(DED) , as well as changes in tear film stability. This prospective study randomly divided 300 children and adolescents with myopia into OK group and spectacles group, with a follow-up of 12 months. At baseline, 1, 3, 6, and 12 months, non-invasive tear breakup time (NIBUT), ocular surface disease index (OSDI) and visual analogue score (VAS) score, tear meniscus height (TMH), conjunctival hyperemia (RS score) and meibomian gland (MG) scores, tear MMP-9 concentration, and point-of-care Lymphotoxin alpha (LTA) test.
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | January 30, 2024 |
Est. primary completion date | November 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 8 Years to 17 Years |
Eligibility | Inclusion Criteria: (i)myopia up to -5.5D; and with-the-rule astigmatism of up to 1.5 DC or against-the rule astigmatism of <-0.5DC with keratometry from 40 to 45D ; (ii)participants and guardians agree to be randomly assigned and are willing to cooperate with doctors for follow-up and examination. Exclusion Criteria: (i) existing ocular trauma, infectious diseases, recent surgical history; (ii) keratitis or any ocular inflammation or infection; recently wearing contact lenses; allergy history; (iii) glaucoma, active uveitis or retinal disease; (iv) systemic diseases. |
Country | Name | City | State |
---|---|---|---|
China | He Eye Hospital | Shenyang | Liaoning |
Lead Sponsor | Collaborator |
---|---|
He Eye Hospital |
China,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Non-invasive tear break-up time | Non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded. | Day-0 (baseline), 1-month ,3-month,6-month and 12-month. | |
Primary | OSDI Score | Chinese translated, and validated OSDI (Allergan Inc, Irvine, USA) version will be used to assess and quantify DE symptom. The 12 items of the questionnaire can be tabulated into a score that ranges from 0 (no symptoms) to 100 (severe symptoms) points. | Day-0 (baseline), 1-month ,3-month,6-month and 12-month. | |
Primary | VAS score | VAS is used to evaluate subjective symptoms, such as patient symptoms, emotions, etc. Composed of a 100 mm straight line, the end is defined as the limit of pain to be measured, resulting in a 100 component scale. The patient rated their eye discomfort by marking the continuity from 'no eye discomfort' (score 0) to 'my eye discomfort is as bad as ever' (score 100). | Day-0 (baseline), 1-month ,3-month,6-month and 12-month. | |
Secondary | Tear meniscus height (TMH) | Tear meniscus height using the Keratograph 5M (Oculus, Germany) topographer | Day-0 (baseline), 1-month ,3-month,6-month and 12-month. | |
Secondary | Conjunctival hyperemia (RS score) | Conjunctival hyperemia (RS score) will be assessed by keratograph image (Oculus, Germany) of 1156*873 pixels, redness score (RS) (accurate to 0.1 U) was displayed on the computer screen that ranged from 0.0 to 4.0. | Day-0 (baseline), 1-month ,3-month,6-month and 12-month. | |
Secondary | Meibomian gland score (meiboscore) | Meibomian gland score will be assessed by keratograph image (Oculus, Germany) .The meibomian gland can be scored that ranges from grade 0 (no loss) to grade 3 (more than two third loss). | Day-0 (baseline), 1-month ,3-month,6-month and 12-month. | |
Secondary | MMP-9 detection | Inflammation Dry, (Rapid Pathogen Screening Inc., Sarasota, FL, USA) is a patented and proprietary modification of a traditional lateral flow device and uses direct sampling microfiltration technology. | Day-0 (baseline), 1-month ,3-month,6-month and 12-month. | |
Secondary | LTA | LTA will be measured using an immunochromatography assay by collecting 1ul tear samples from the lateral canthus using a capillary tear collector. To assess the concentration of LTA in the tear samples, a commercial reagent card (S05B, Seinda Biomedical Corporation, Guangdong, China) based on colloidal gold and immunochromatographic analysis was utilized. | Day-0 (baseline), 1-month ,3-month,6-month and 12-month. |
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