Contact Lens ComplicationNCT06650306
The Impact of Soft Contact Lenses on the Corneal Neuromediators and Optical Quality in High Myopia Prior to SMILE
An observational study of Contact Lens Complication, run by yuhao shao at 1 site in China.
Trial summary
To investigate the influence of Neuromediators expression in corneal stromal lenticules and corneal injury repair after small incision extraction Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Contact Lens Complication
- What is being tested?
- This study does not involve any interventions
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2024to 30 Jun 2026
- 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 with high myopia who underwent SMILE surgery at Shanghai Tenth People's Hospital in Shanghai, China, between October 2020 and October 2023.
Who may be able to join
- age ≥ 18 years with stable refraction for at least two years;
- spherical equivalent (SE) < -6.00 D;
- corrected distance visual acuity of 20/20 or better;
- no history of using rigid gas permeable lenses or orthokeratology (OK) lenses prior to examination
Who cannot join
- a history of moderate to severe dry eye as well as any ocular or systemic disease that would contraindicate laser refractive surgery.
Trial locations and contacts
1 site in 1 country.
About this study
To investigate the influence of Neuromediators expression in corneal stromal lenticules and corneal injury repair after small incision extraction
Read the detailed description
This study included 160 eyes from high myopia patients who underwent Small Incision Lenticule Extraction. Patients were devided into three groups based on duration of wearing SCLs: > 10 years group, ≤ 10 years group, and NW group (not SCLs). Corneal higher-order aberrations and densitometry were evaluated using a Pentacam system. Neuromediator levels in corneal stromal lenticules were analyzed using ELISA and immunofluorescence
- Conditions
- Contact Lens Complication
- Being tested
- This study does not involve any interventions
- Keywords
- Corneal Neuromediator, Soft contact lenses, Corneal optical density, Corneal aberration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This study does not involve any interventionsOther
This study does not involve any interventions
| Study group | Role | What they receive |
|---|---|---|
| SCLs >10 years | high myopia patients who wear SCL more than 10 years before Small Incision Lenticule Extraction Receives: Other: This study does not involve any interventions | |
| SCLs ≤10 years | high myopia patients who wear SCL for 10 years or less before Small Incision Lenticule Extraction Receives: Other: This study does not involve any interventions | |
| NW | high myopia patients who have not worn SCLs before Small Incision Lenticule Extraction Receives: Other: This study does not involve any interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal stromal lenticule Neuromediators
Corneal neuromediators, including NGF(pg/mL), CGRP(pg/mL), SP(pg/mL), IGFBP-1(ng/mL), and MANF(pg/mL), which play pivotal roles in maintaining normal physiological functions of the cornea.
Measured: baseline
Secondary outcomes (2)
Corneal Aberration
Preoperative corneal aberration measurements were performed using a Scheimpflug tomography system (Pentacam; Oculus GmbH, Wetzlar, Germany). Images of the highest quality (designated as OK) were selected for analysis. The coefficients for a standardized diameter of 8 ?mm were examined, followed by an assessment of the clinical significance of total higher-order aberrations (HOA, mm), spherical aberration (Z4, 0, mm), horizontal coma (Z3, 1, mm), vertical coma (Z3, -1, mm), horizontal trefoil (Z3, 3, mm), and oblique trefoil (Z3, -3, mm) in relation to visual quality.
Measured: baseline
Corneal Densitometry
The Pentacam HR was used to collect data on corneal densitometry values, which were expressed in grayscale units (GSUs), playing a crucial role in quantifying corneal clarity by monitoring transient haze-like reactions. The cornea was divided into four annular zones (0-2 mm, 2-6 mm, 6-10 mm, and 10-12 mm), each exhibiting distinct corneal densitometry values. Based on the anatomical layers of the cornea at different depths, it consists of four layers: a superficial anterior layer of 120 μm, a posterior layer located within the innermost part of the cornea measuring 60 μm; central layers calculated by subtracting thickness of the anterior and posterior layers from the total layer thickness; and a total layer. Corneal densitometry values were measured in the 0-2 mm and 2-6 mm to correspond to the corneal optical zone diameter of SMILE.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start18 Oct 2024
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contact Lens ComplicationStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- yuhao shao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, yuhao shao, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650306
- Sponsor's protocol ID
- SHSY-IEC-5.0/23K74/P01
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2024
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Soft Contact Lenses on the Corneal Neuromediators and Optical Quality in High Myopia Prior to SMILE
- ClinicalTrials.gov ID
- NCT06650306
- Acronym / sponsor ID
- SHSY-IEC-5.0/23K74/P01
- Conditions
- Contact Lens Complication
- Keywords
- Corneal Neuromediator, Soft contact lenses, Corneal optical density, Corneal aberration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- yuhao shaoUniversity, hospital or other
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 21 Oct 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.
To investigate the influence of Neuromediators expression in corneal stromal lenticules and corneal injury repair after small incision extraction
Detailed description
This study included 160 eyes from high myopia patients who underwent Small Incision Lenticule Extraction. Patients were devided into three groups based on duration of wearing SCLs: > 10 years group, ≤ 10 years group, and NW group (not SCLs). Corneal higher-order aberrations and densitometry were evaluated using a Pentacam system. Neuromediator levels in corneal stromal lenticules were analyzed using ELISA and immunofluorescence
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SCLs >10 years | – | Other: This study does not involve any interventionshigh myopia patients who wear SCL more than 10 years before Small Incision Lenticule Extraction |
| SCLs ≤10 years | – | Other: This study does not involve any interventionshigh myopia patients who wear SCL for 10 years or less before Small Incision Lenticule Extraction |
| NW | – | Other: This study does not involve any interventionshigh myopia patients who have not worn SCLs before Small Incision Lenticule Extraction |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- patients with high myopia who underwent SMILE surgery at Shanghai Tenth People's Hospital in Shanghai, China, between October 2020 and October 2023.
Key inclusion criteria (4 listed)
- age ≥ 18 years with stable refraction for at least two years;
- spherical equivalent (SE) < -6.00 D;
- corrected distance visual acuity of 20/20 or better;
- no history of using rigid gas permeable lenses or orthokeratology (OK) lenses prior to examination
Key exclusion criteria (1 listed)
- a history of moderate to severe dry eye as well as any ocular or systemic disease that would contraindicate laser refractive surgery.
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 |
|---|---|---|
| This study does not involve any interventionsThis study does not involve any interventions | Other | NW, SCLs >10 years, SCLs ≤10 years |
Primary outcome
Corneal stromal lenticule Neuromediators
Time frame: baseline
Corneal neuromediators, including NGF(pg/mL), CGRP(pg/mL), SP(pg/mL), IGFBP-1(ng/mL), and MANF(pg/mL), which play pivotal roles in maintaining normal physiological functions of the cornea.
2 secondary outcomes
Corneal Aberration
Time frame: baseline
Corneal Densitometry
Time frame: baseline
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 20 Oct 2026.
- Individual participant dataSharing planned: No
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 Contact Lens Complication, run by yuhao shao 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 4 inclusion and 1 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 20 Oct 2026. 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?
Corneal stromal lenticule Neuromediators (time frame: baseline). 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 20 Oct 2026.