Refractive Surgery Clinical Trial
Official title:
Analysis of Factors Associated With Threatened Aspiration in Patients Undergoing Small-incision Lenticule Extraction (SMILE) : Prospective Study
The goal of this Prospective observational studiesis to Characteristics of progressive suction loss.
Status | Recruiting |
Enrollment | 800 |
Est. completion date | December 1, 2024 |
Est. primary completion date | July 1, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: 1. Age = 18 years; 2. Stable refractive state in the last 2 years, with yearly change in refractive power = 0.50 D; 3. Spherical power = -10.00D, cylindrical power = -3.00 D; 4. Best Corrected Visual Acuity (BCVA) = 16/20; 5. No use of corneal contact lenses two weeks before surgery. Exclusion Criteria: 1. Eye diseases or histories beyond myopia and astigmatism, such as keratoconus; 2. Previous eye surgeries or histories of systemic illnesses; 3. Severe mental disorders like generalized anxiety disorder, panic disorder, depression, psychosis, and bipolar disorder, impeding cooperation with the doctor. |
Country | Name | City | State |
---|---|---|---|
China | Yuyifeng | Nanchang | Jiangxi |
Lead Sponsor | Collaborator |
---|---|
Yifeng Yu |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identify risk factors for progressive suction loss | Progressive suction loss, the precursors to the loss of suction are quite evident. This study involved reviewing surgical videos and classifying patients into normal and progressive suction loss groups based on diagnostic criteria for progressive suction loss proposed by Huang. The intruding gas, liquid, and conjunctival tissue were analyzed using the ImageJ image processing software. Progressive suction loss was classified into three groups based on severity: Group A, where bubbles and wet spots begin to appear at the contact area between the suction ring and the corneal edge; Group B, where the area of bubbles and wet spots increases, exceeding 5% of the contact area as analyzed by ImageJ, but not spreading to the corneal surface; Group C, where bubbles and wet spots spread to the corneal surface, even affecting the laser scanning area. | 2024-12-01 |
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