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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06264804
Other study ID # [2023] No. 86
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 16, 2024
Est. completion date December 1, 2024

Study information

Verified date April 2024
Source Second Affiliated Hospital of Nanchang University
Contact yifeng yu
Phone 13979180258
Email 171018170@qq.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this Prospective observational studiesis to Characteristics of progressive suction loss.


Description:

The goal of this Prospective observational studiesis to Characteristics of progressive suction loss. The main question[s] it aims to answer are: • Characteristics of people who do not develop progressive aspiration Characteristics of people with progressive aspiration Participants will The differences between the two groups were compared


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Yuyifeng Nanchang Jiangxi

Sponsors (1)

Lead Sponsor Collaborator
Yifeng Yu

Country where clinical trial is conducted

China, 

Outcome

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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