Impact of Soft Contact Lenses on Corneal Health in High Myopia

The Impact of Soft Contact Lenses on the Corneal Neuromediators and Optical Quality in High Myopia Prior to SMILE

This study looks at how wearing soft contact lenses for different lengths of time affects the eye's health and vision quality in people with high myopia before they have a specific eye surgery.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years to 45 Years
• Sex: All
• Sponsor: Tongji University (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06650306 on ClinicalTrials.gov

What this trial studies

This observational study investigates how the duration of soft contact lens (SCL) wear affects corneal neuromediator expression and optical quality in patients with high myopia prior to undergoing Small Incision Lenticule Extraction (SMILE). A total of 160 eyes from eligible participants are categorized into three groups based on their SCL usage: those who have worn them for more than 10 years, those who have worn them for 10 years or less, and those who have never worn SCLs. The study evaluates corneal higher-order aberrations and optical density using advanced imaging techniques, while also analyzing neuromediator levels in corneal stromal lenticules through laboratory methods. The findings aim to enhance understanding of corneal health in relation to contact lens use.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with high myopia and stable vision who have been using soft contact lenses.

Not a fit: Patients with a history of moderate to severe dry eye or other ocular/systemic diseases that contraindicate laser surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into optimizing contact lens use and improving corneal health for patients with high myopia.

How similar studies have performed: While there have been studies on contact lens effects, this specific investigation into neuromediators and optical quality in high myopia is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

\- a history of moderate to severe dry eye as well as any ocular or systemic disease that would contraindicate laser refractive surgery.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Tenth People's Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: min Li, Dr

Conditions Contact Lens Complication; Corneal Neuromediator; Soft contact lenses; Corneal optical density; Corneal aberration