Using scleral lenses to treat ocular surface diseases
Clinical Application Research of Scleral Lenses in Ocular Surface Diseases
This study is testing if scleral lenses can help people with irregular corneal astigmatism feel more comfortable and see better due to their eye surface problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06555367 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of scleral lenses in improving visual acuity, comfort, and satisfaction in patients with irregular corneal astigmatism due to ocular surface diseases. Participants undergo thorough ophthalmic evaluations, including corneal topography and tear film analysis, before being fitted with scleral lenses. Follow-up assessments occur at one week, one month, and three months post-fitting to measure outcomes such as visual acuity and comfort levels. Statistical methods are employed to analyze the data and compare pre- and post-intervention results.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with irregular corneal astigmatism related to ocular surface diseases.
Not a fit: Patients with acute ocular inflammation, infection, or those unable to comply with lens hygiene may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance the quality of life for patients suffering from irregular corneal astigmatism by improving their vision and comfort.
How similar studies have performed: Previous studies have shown promising results with scleral lenses in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with irregular corneal astigmatism, including those with post-keratoconus cross-linking surgery, post-keratoplasty, and corneal irregularities caused by trauma; Volunteers who are willing to participate in this trial, have signed the informed consent form, and are willing to cooperate with the treatment and follow-up; Individuals aged 18 years or older (including 18 years old), with no gender restrictions; Cases collected from January 2023 to August 2024. Exclusion Criteria: * Unable or unwilling to sign the consent form, or unable to follow the study procedures; Nursing or pregnant women; Individuals with acute ocular inflammation or infection; Corneal endothelium: Cell Density (CD) \<1000/mm²; Individuals required to wear lenses overnight; Poor compliance; Those who do not meet the hygiene requirements for lens wear; Individuals whom the investigator deems have other reasons making them unsuitable for the trial.
Where this trial is running
Hangzhou, Zhejiang
- Second Affiliated Hospital of Zhejiang University Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: ming xiu jin
- Email: 18344980412@qq.com
- Phone: 13989455778
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.