Risk Factors for Progressive Suction Loss in Corneal Refractive Surgery

NCT ID: NCT06264804

Last Updated: 2024-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-16

Study Completion Date

2024-12-01

Brief Summary

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

Detailed Description

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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

Conditions

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Refractive Surgery

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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progressive suction loss group

Progressive suction loss occurs during the SMILE procedure

No interventions assigned to this group

Normal group

There was no progressive suction during the SMILE procedure

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yifeng Yu

OTHER

Sponsor Role lead

Responsible Party

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Yifeng Yu

Deputy Chief Physician of Ophthalmology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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yifeng yu

Role: STUDY_DIRECTOR

Second Affiliated Hospital of Nanchang University

Locations

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Yuyifeng

Nanchang, Jiangxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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yifeng yu

Role: CONTACT

13979180258

Facility Contacts

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yifeng Yu, Doctorate

Role: primary

+8613979180258

Other Identifiers

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[2023] No. 86

Identifier Type: -

Identifier Source: org_study_id

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