CompletedNot Applicable

Long-term Effects of SCL-wearing on Corneal Neuromediators and Postoperative Rehabilitation After SMILE

China90 participantsStarted 2023-06-01

Plain-language summary

To investigate the effects of neuromediators in corneal stromal lenticules from patients with long-term soft contact lens (SCL) wear on corneal nerve regeneration and visual quality recovery following small incision lenticule extraction (SMILE).

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age ≥ 18 years with stable refraction for at least two years; * 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Quality of Vision (QOV) scores

Timeframe: baseline, 1 month, 3months, 6months

contrast sensitivity function

Timeframe: baseline, 1moth, 3 moths, 6 months

Corneal subepithelial nerve fibers

Timeframe: baseline, 1moth, 3 moths, 6 months

Corneal stromal lenticule Neuromediators

Timeframe: baseline

OSDI Questionnaire

Timeframe: baseline, 1moth, 3 moths, 6 months

Trial details

NCT IDNCT07001306

Sponsoryuhao shao

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-06-30

View on ClinicalTrials.gov More Contact Lens Complication trials

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Quality of Vision (QOV) scores

Timeframe: baseline, 1 month, 3months, 6months

contrast sensitivity function

Timeframe: baseline, 1moth, 3 moths, 6 months

Corneal subepithelial nerve fibers

Timeframe: baseline, 1moth, 3 moths, 6 months

Corneal stromal lenticule Neuromediators

Timeframe: baseline

OSDI Questionnaire

Timeframe: baseline, 1moth, 3 moths, 6 months