Clinical Application Research of Scleral Lenses in Ocular Surface Diseases

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Second Affiliated Hospital of Zhejiang University Hospital
RECRUITING
Hangzhou
Contact Information
Primary
ming xiu jin
18344980412@qq.com
13989455778
Backup
rui yi zhu
zhuyirui001@126.com
15868805518
Time Frame
Start Date: 2024-08-08
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 20
Treatments
scleral lenses group
The case group consists of patients with irregular corneas who wear scleral lenses.
control group
The control group comprises patients with irregular corneas who have not undergone treatment with scleral lenses.
Related Therapeutic Areas
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov