MyopiaNCT05367154
Factor Analysis of Unintended Initial Dissection of the Posterior Plane
An observational study of Myopia and Small-incision Lenticule Extraction (SMILE) Surgery, run by Yifeng Yu at 1 site in China.
Trial summary
To explore the potential factors for unintended initial dissection of the posterior plane in a large sample retrospective analysis and surgeons of different levels. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia, Small-incision Lenticule Extraction (SMILE) Surgery
- What is being tested?
- Small incision lenticule extraction
- Type of treatment
- Surgery or procedure
- How many people
- 3,003 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2021to 1 Sep 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients from clinics in ophthalmic center of the second Affiliated Hospital of Nanchang University
Who may be able to join
- A condition in which the spherical equivalent refractive error of an eye is ≤ -0.50 D when ocular accommodation is relaxed;
- Age ≥18 years;
- Spherical equivalent (SE) ≥ -10.0D;
- Corrected distance visual acuity (CDVA) ≥ 16/20;
- Stable myopia for at least 2 years;
- No contact lenses wearing for at least 2 weeks.
Who cannot join
- The presence or history of eye conditions other than myopia and astigmatism, such as keratoconus or external eye injury;
- A history of eye surgery;
- The presence or history of systemic diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000
About this study
Official title: Identification of Factors Related to Unintended Initial Dissection of the Posterior Plane in Small Incision Lenticule Extraction Cases by Three Different Surgeons
To explore the potential factors for unintended initial dissection of the posterior plane in a large sample retrospective analysis and surgeons of different levels.
Read the detailed description
Myopia is the most common eye disease in the world. Femtosecond laser small incision lens extraction (SMILE) has increasingly become the first choice in refractive surgery due to its greater biomechanical stability, less impact on the tear film and other advantages. However, because SMILE surgery is more challenging than flap-based corneal ablative surgery, young surgeons sometimes dissect the lenticule posterior plane first in clinical practice, which will make it more difficult to extract the lenticule or even cause the retained lenticule. The purpose of this study aims to explore the potential risk factors for unintended initial dissection of the posterior plane in large samples and surgeons of different surgical volumes and different surgical habits (different angles of peripheral corneal incision) in multiple scenarios.
- Being tested
- Small incision lenticule extraction
- Keywords
- femtosecond laser, small-incision lenticule extraction (SMILE), unintended initial dissection of the posterior plane
- Medical subject headings
- Myopia, Smiling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small incision lenticule extractionProcedure or surgery
Small incision lenticule extraction surgeries performed by two Refractive surgery experts (Refractive surgery expert 1: YYF, Associate Professor with 10 years of experience as a refractive surgeon; Refractive surgery expert 2: GF, Associate Professor with 5 years of experience as a refractive surgeon) and a Attending ophthalmologist (WNY, Attending ophthalmologist with 1 year of experience as a refractive surgeon).
| Study group | Role | What they receive |
|---|---|---|
| Eyes with SMILE surgeries | Eyes with SMILE surgeries which were performed by three surgeons with different experiences. Receives: Procedure: Small incision lenticule extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with unintended initial dissection of the posterior plane in the SMILE surgeries
The number of patients with unintended initial dissection of the posterior plane were observed during the SMILE surgeries.
Measured: Day 0
Secondary outcomes (5)
The impact of spherical equivalent on the unintended initial dissection of the posterior plane (UIDPP) in SMILE surgeries
The spherical equivalent of eyes with UIDPP and eyes without UIDPP were analyzed, and statistical analysis was observed to investigate the impact of spherical equivalent on the UIDPP in SMILE surgeries.
Measured: Day 0
The impact of peripheral corneal incision angle on the unintended initial dissection of the posterior plane (UIDPP) in SMILE surgeries
The peripheral corneal incision angle of eyes with UIDPP and eyes without UIDPP were analyzed, and statistical analysis was observed to investigate the impact of peripheral corneal incision angle on the UIDPP in SMILE surgeries.
Measured: Day 0
The impact of peripheral lens thickness on the unintended initial dissection
The peripheral lens thickness of eyes with UIDPP and eyes without UIDPP were analyzed, and statistical analysis was observed to investigate the impact of peripheral corneal incision angle on the UIDPP in SMILE surgeries.
Measured: Day 0
The impact of lens diameter on the unintended initial dissection
The lens diameter of eyes with UIDPP and eyes without UIDPP were analyzed, and statistical analysis was observed to investigate the impact of lens diameter on the UIDPP in SMILE surgeries.
Measured: Day 0
The impact of central corneal thickness on the unintended initial dissection
The central corneal thickness of eyes with UIDPP and eyes without UIDPP were analyzed, and statistical analysis was observed to investigate the impact of central corneal thickness on the UIDPP in SMILE surgeries.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start1 Apr 2021
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Other
- Enrolment
- 3,003 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367154
- Sponsor's protocol ID
- [2021] No. (031)
- Status last verified
- May 2022
- First submitted
- 29 Apr 2022
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Factors Related to Unintended Initial Dissection of the Posterior Plane in Small Incision Lenticule Extraction Cases by Three Different Surgeons
- ClinicalTrials.gov ID
- NCT05367154
- Acronym / sponsor ID
- [2021] No. (031)
- Keywords
- femtosecond laser, small-incision lenticule extraction (SMILE), unintended initial dissection of the posterior plane
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,003 participants (actual)
- Lead sponsor
- Yifeng YuUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 10 May 2022 (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.
To explore the potential factors for unintended initial dissection of the posterior plane in a large sample retrospective analysis and surgeons of different levels.
Detailed description
Myopia is the most common eye disease in the world. Femtosecond laser small incision lens extraction (SMILE) has increasingly become the first choice in refractive surgery due to its greater biomechanical stability, less impact on the tear film and other advantages. However, because SMILE surgery is more challenging than flap-based corneal ablative surgery, young surgeons sometimes dissect the lenticule posterior plane first in clinical practice, which will make it more difficult to extract the lenticule or even cause the retained lenticule. The purpose of this study aims to explore the potential risk factors for unintended initial dissection of the posterior plane in large samples and surgeons of different surgical volumes and different surgical habits (different angles of peripheral corneal incision) in multiple scenarios.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eyes with SMILE surgeries | – | Procedure: Small incision lenticule extractionEyes with SMILE surgeries which were performed by three surgeons with different experiences. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients from clinics in ophthalmic center of the second Affiliated Hospital of Nanchang University
Key inclusion criteria (6 listed)
- A condition in which the spherical equivalent refractive error of an eye is ≤ -0.50 D when ocular accommodation is relaxed;
- Age ≥18 years;
- Spherical equivalent (SE) ≥ -10.0D;
- Corrected distance visual acuity (CDVA) ≥ 16/20;
- Stable myopia for at least 2 years;
Key exclusion criteria (3 listed)
- The presence or history of eye conditions other than myopia and astigmatism, such as keratoconus or external eye injury;
- A history of eye surgery;
- The presence or history of systemic diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Small incision lenticule extractionSmall incision lenticule extraction surgeries performed by two Refractive surgery experts (Refractive surgery expert 1: YYF, Associate Professor with 10 years of experience as a refractive surgeon; Refractive surgery expert 2: GF, Associate Professor with 5 years of experience as a refractive surgeon) and a Attending ophthalmologist (WNY, Attending ophthalmologist with 1 year of experience as a refractive surgeon). | Procedure or surgery | Eyes with SMILE surgeries |
Primary outcome
The number of patients with unintended initial dissection of the posterior plane in the SMILE surgeries
Time frame: Day 0
The number of patients with unintended initial dissection of the posterior plane were observed during the SMILE surgeries.
5 secondary outcomes
The impact of spherical equivalent on the unintended initial dissection of the posterior plane (UIDPP) in SMILE surgeries
Time frame: Day 0
The impact of peripheral corneal incision angle on the unintended initial dissection of the posterior plane (UIDPP) in SMILE surgeries
Time frame: Day 0
The impact of peripheral lens thickness on the unintended initial dissection
Time frame: Day 0
The impact of lens diameter on the unintended initial dissection
Time frame: Day 0
The impact of central corneal thickness on the unintended initial dissection
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Individual participant dataSharing planned: No
Related trials for Myopia
Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Myopia and Small-incision Lenticule Extraction (SMILE) 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 6 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: finished, as of the sponsor's last update on 10 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients with unintended initial dissection of the posterior plane in the SMILE surgeries (time frame: Day 0). 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 10 May 2022.