Clinical Application Research of Scleral Lenses in Ocular Surface Diseases

Zhejiang University

Status: Enrolling

Conditions: Ocular Surface Disease

Treatments: Device: scleral lenses

Study type: Observational

Funder types: Other

Identifiers

NCT06555367

2024-0667

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

20 participants in 2 patient groups

scleral lenses group

Description:

The case group consists of patients with irregular corneas who wear scleral lenses.

Treatment:

Device: scleral lenses

control group

Description:

The control group comprises patients with irregular corneas who have not undergone treatment with scleral lenses.