Status:
NOT_YET_RECRUITING
Effects of 3% Diquafosol on Tear Film and Vision-related Quality of Life in Orthokeratology Lens Related Dry Eye
Lead Sponsor:
He Eye Hospital
Conditions:
Dry Eye
Eligibility:
All Genders
8-18 years
Phase:
NA
Brief Summary
Investigate the effect of 3% Diquafosol on tear film and vision-related quality of life in dry eye patients wearing orthokeratology lenses(OK lens), and to provide reference for clinical treatment.Thi...
Detailed Description
Keratoplasty is gaining popularity worldwide as a method of controlling myopia progression. Several clinical studies have shown that overnight wear of Orthokeratology lenses (OK) is an effective metho...
Eligibility Criteria
Inclusion
- Age 8-18 years old
- Wearing corneal shape mirror more than one year and at least eight hours every night
- Myopia -5.50 to -1.00 D, astigmatism \< 1.75 D, or curvature between 41.00 and 46.00D, astigmatism \< -0.75D, and best corrected visual acuity ≥1.0.
- Diagnosis of dry eye: patients complained of dry eye, foreign body sensation, burning sensation, fatigue, discomfort, envy, subjective symptom such as vision fluctuation; (a) OSDI questionnaire score \>13 points, and (b) NITBUT \<10 s or (c) ocular surface dyeing assessment \> 5 corneal spots/more than nine conjunctival spots.
- Participants were able to use eye drops as required, complete examinations, and return to the hospital for follow-up examinations within the specified time to complete follow-up.
Exclusion
- Suffering from allergic or autoimmune disease associated with dry eye of the participants are not suitable for wearing OK lens
- Pathological changes in the corneal rim
- Eyelid rim lesions, cornea, uveitis, retina and other systemic diseases may affect the ocular surface. Examples include severe ocular surface diseases (Sjögren's syndrome, allergic conjunctivitis, ocular papules, conjunctival chafing, conjunctival scarring, and chemical damage);
- Received any dry eye treatment within 14 days prior to the start of this study or continued use of other topical eye drops that would affect the results of the study.
- Have received any other eye treatment or surgery
Key Trial Info
Start Date :
August 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06537349
Start Date
August 15 2024
End Date
December 31 2024
Last Update
August 12 2024
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