Risk Factors for Progressive Suction Loss in Corneal Refractive Surgery

Refractive Surgery Clinical Trial

Official title:

Analysis of Factors Associated With Threatened Aspiration in Patients Undergoing Small-incision Lenticule Extraction (SMILE) : Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06264804
• Other study ID #: [2023] No. 86
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Refractive Surgery

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