Clinical Application Research of Scleral Lenses in Ocular Surface Diseases
Recruiting now
Conditions studied: Ocular Surface Disease
In brief
To evaluate the therapeutic efficacy of scleral lenses in patients with irregular corneal astigmatism stemming from ocular surface diseases (OSD), focusing on visual acuity improvement, comfort, and overall satisfaction. This prospective clinical study enrolled patients diagnosed with OSD-related irregular corneal astigmatism. Participants underwent comprehensive ophthalmic evaluation, including corneal topography, visual acuity assessment, and tear film analysis. Qualified subjects were fitted with scleral lenses and followed up at intervals of one week, one month, and three months post-fitting. The primary outcomes measured were uncorrected and corrected visual acuity, comfort levels assessed via a standardized questionnaire, and fitting success rates. Data were analyzed using appropriate statistical methods to compare pre- and post-intervention values.
Key facts
- Study ID
- NCT06555367
- Run by
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- People needed
- 20
- Starts
- 2024-08-08
- Expected to finish
- 2026-08-31
- Last updated by the study team
- 2024-08-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 it is running
- Second Affiliated Hospital of Zhejiang University Hospital — Hangzhou, Zhejiang, China (enrolling)
Full record on ClinicalTrials.gov
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