Risk Factors for Progressive Suction Loss in Corneal Refractive Surgery

NCT06264804 | Recruiting DMC

• 1 other identifier: [2023] No. 86
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Refractive Surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

progressive suction loss group

Progressive suction loss occurs during the SMILE procedure

Normal group

There was no progressive suction during the SMILE procedure

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

all

You may qualify if:

• Age ≥ 18 years;
• Stable refractive state in the last 2 years, with yearly change in refractive power ≤ 0.50 D;
• Spherical power ≤ -10.00D, cylindrical power ≤ -3.00 D;
• Best Corrected Visual Acuity (BCVA) ≥ 16/20;
• No use of corneal contact lenses two weeks before surgery.

You may not qualify if:

• Eye diseases or histories beyond myopia and astigmatism, such as keratoconus;
• Previous eye surgeries or histories of systemic illnesses;
• Severe mental disorders like generalized anxiety disorder, panic disorder, depression, psychosis, and bipolar disorder, impeding cooperation with the doctor.

Sponsors & Collaborators

• Yifeng Yu: lead

Study Sites (1)

Yuyifeng

Nanchang, Jiangxi, 330008, China

RECRUITING

Study Officials

• yifeng yu

  Second Affiliated Hospital of Nanchang University

  STUDY DIRECTOR

Central Study Contacts

yifeng yu

CONTACT

13979180258; 171018170@qq.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief Physician of Ophthalmology

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: February 20, 2024
• Study Start: February 16, 2024
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-04

Locations

CN (1)