Risk Factors for Progressive Suction Loss in Corneal Refractive Surgery

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06264804

Enrollment

800

Registered

2024-02-20

Start date

2024-02-16

Completion date

2024-12-01

Last updated

2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractive Surgery

Brief summary

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

Detailed 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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Identify risk factors for progressive suction loss	2024-12-01	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.

Countries

China

Contacts

Primary Contactyifeng yu

171018170@qq.com13979180258

Outcome results