Clinical Application Research of Scleral Lenses in Ocular Surface Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: scleral lenses.
- Who it may be relevant to
- Registry conditions: Ocular Surface Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device scleral lenses
Wear scleral lenses
Primary outcome measures
- Scleral lens fitting assessment [Time frame: 4 hours later]
Secondary outcome measures (1)
- Subjective comfort assessment [Time frame: 4 hours later]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
China · 1 center
- Second Affiliated Hospital of Zhejiang University Hospital — Hangzhou
Publications
- Zhu Y, Cai J, Su L, Dong J, Zhou J, Zheng H, Mou Y, Jin X. Comparative Evaluation of Scleral Lens Treatment in Ocular Surface Diseases: A Prospective Study. J Ophthalmol. 2026 May 23;2026:1921583. doi: 10.1155/joph/1921583. eCollection 2026. PMID 42183401
Identifiers
NCT: NCT06555367 · 2024-0667