Myopia or myopic astigmatism
Conditions
Interventions
None listed
Sponsors
Toda Ikuko
Murakami Koichi
STAAR Surgical KK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Individuals with myopia or myopic astigmatism in both eyes 2) Individuals who wish to undergo ICL surgery 3) Individuals who have been wearing contact lenses (CL) through to the time that consent is obtained 4) Individuals who, at the time of obtaining consent, have subjective symptoms, such as ocular discomfort or visual function abnormalities, as defined by the diagnostic criteria for dry eye 5) Male or female individuals who are aged between 21 and 45 years at the time of obtaining consent 6) Individuals who understand the explanatory document and have provided written informed consent at their own free will
Exclusion criteria
Exclusion criteria: 1) Individuals with ophthalmic diseases other than refractive errors 2) Individuals with refractive changes within the one-year period prior to surgery exceeds 0.50D 3) Individuals with an anterior chamber depth of less than 2.8 mm 4) Individuals with a cataract or opacity of the crystalline lens 5) Individuals with a history of hypersensitivity (allergy) to collagen 6) Individuals with insulin-dependent diabetes mellitus 7) Individuals with a history of other refractive surgery and/or intraocular surgery 8) Pregnant or lactating individuals 9) Individuals with a narrow anterior chamber angle 10) Any other individuals deemed inappropriate as subjects for the Research by the researchers, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from preoperative baseline in tear film break-up time (TBUT) at one month after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Mean change from preoperative baseline in tear film break-up time (TBUT) at three months after surgery 2) Change in fluorescein staining score at one month and three months after surgery (compared with the preoperative value) 3) Summary of patient responses in the DEQS (Dry Eye-related Quality of Life Score (10) and QOL questionnaire at the initial visit, before surgery, one month after surgery, and three months after surgery 4) Mean change in TBUT before surgery (without contact lenses) compared with the initial visit (with contact lenses) | — |
Contacts
Public ContactIkuko Toda
Minamiaoyama Eye Clinic
Outcome results
None listed