Refractive SurgeryNCT06264804
Risk Factors for Progressive Suction Loss in Corneal Refractive Surgery
An observational study of Refractive Surgery, run by Yifeng Yu at 1 site in China.
Trial summary
The goal of this Prospective observational studiesis to Characteristics of progressive suction loss. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Surgery
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 16 Feb 2024to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: all
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yuyifeng
Nanchang, Jiangxi, 330008
yifeng Yu, Doctorate, +8613979180258, 171018170@qq.com
About this study
Official title: Analysis of Factors Associated With Threatened Aspiration in Patients Undergoing Small-incision Lenticule Extraction (SMILE) : Prospective Study
The goal of this Prospective observational studiesis to Characteristics of progressive suction loss.
Read the 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
- Conditions
- Refractive Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| progressive suction loss group | Progressive suction loss occurs during the SMILE procedure | |
| Normal group | There was no progressive suction during the SMILE procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2024-12-01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start16 Feb 2024
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractive SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yifeng Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yifeng Yu, Second Affiliated Hospital of Nanchang University
- Investigators
- yifeng yu, Study director, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264804
- Sponsor's protocol ID
- [2023] No. 86
- Status last verified
- Apr 2024
- First submitted
- 10 Jan 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Factors Associated With Threatened Aspiration in Patients Undergoing Small-incision Lenticule Extraction (SMILE) : Prospective Study
- ClinicalTrials.gov ID
- NCT06264804
- Acronym / sponsor ID
- [2023] No. 86
- Conditions
- Refractive Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Yifeng YuUniversity, hospital or other
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| progressive suction loss group | – | –Progressive suction loss occurs during the SMILE procedure |
| Normal group | – | –There was no progressive suction during the SMILE procedure |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- all
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identify risk factors for progressive suction loss
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
yifeng yu study director
Second Affiliated Hospital of Nanchang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractive Surgery, run by Yifeng Yu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yifeng yu (13979180258, 171018170@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify risk factors for progressive suction loss (time frame: 2024-12-01). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.