Actively Recruiting
Clinical Application Research of Scleral Lenses in Ocular Surface Diseases
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-08-15
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of scleral lenses for patients with irregular corneal astigmatism caused by various ocular surface diseases. This prospective clinical study focuses on how scleral lenses may improve vision clarity, comfort, and patient satisfaction. Patients with corneal irregularities from conditions like post-keratoconus surgery, post-keratoplasty, or trauma are enrolled to assess these lenses' effects. Participants are divided into two groups: one group will wear scleral lenses while the other group will not receive this treatment. The study includes comprehensive eye exams, such as corneal topography, visual acuity testing, and tear film analysis. Those fitted with scleral lenses are followed up at one week, one month, and three months after fitting to evaluate lens success and comfort. Throughout the study, participants undergo vision tests and complete comfort questionnaires. The main measurement is scleral lens fitting success assessed four hours after application, along with subjective comfort evaluations. Researchers compare vision and comfort before and after lens use. The study spans from initial assessment through three months of follow-up to monitor outcomes and satisfaction.
CONDITIONS
Brief Title
Clinical Application Research of Scleral Lenses in Ocular Surface Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with irregular corneal astigmatism, including post-keratoconus cross-linking surgery, post-keratoplasty, and trauma-related corneal irregularities
- Volunteers willing to participate, sign informed consent, and cooperate with treatment and follow-up
- Age 18 years or older, with no gender restrictions
- Cases collected from January 2023 to August 2024
You will not qualify if you...
- Unable or unwilling to sign consent or follow study procedures
- Nursing or pregnant women
- Individuals with acute ocular inflammation or infection
- Corneal endothelial cell density less than 1000/mm²
- Individuals required to wear lenses overnight
- Poor compliance or hygiene for lens wear
- Other reasons deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 4 hours
Participants in the scleral lenses group wear scleral lenses as part of the study.
1 visit (in-person)
Duration - 4 hours after lens fitting
Participants are observed to assess scleral lens fitting and subjective comfort after lens wear.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital of Zhejiang University Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
M
ming xiu jin
R
rui yi zhu
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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