Clinical Application Research of Scleral Lenses in Ocular Surface Diseases

NCT06555367 | Recruiting

• 1 other identifier: 2024-0667
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ocular Surface Disease

Outcome Measures

Primary Outcomes (1)

• Scleral lens fitting assessment

  The fitting assessment is conducted using a slit lamp microscope to observe the central positioning of the lens, the tear film space under the lens, and the vascular compression on the peripheral conjunctival surface. OCT is applied to measure the tear film space between the central and peripheral non-contact areas of the lens and the anterior corneal surface, as well as the landing zone of the lens in all peripheral directions.

  4 hours later

Secondary Outcomes (1)

• Subjective comfort assessment

  4 hours later

Study Arms (2)

scleral lenses group

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

Device: scleral lenses

control group

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

Interventions

scleral lenses DEVICE

Wear scleral lenses

scleral lenses group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with irregular corneal astigmatism who visited the ophthalmology clinic of the Second Affiliated Hospital of Zhejiang University for scleral lens fitting from January 2022 to June 2024 were selected. This includes patients with post-keratoconus cross-linking surgery, post-keratoplasty, and those with corneal irregularities caused by trauma.

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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital of Zhejiang University Hospital

Hangzhou, Zhejiang, China

RECRUITING

Central Study Contacts

ming xiu jin

CONTACT

13989455778; 18344980412@qq.com

rui yi zhu

CONTACT

15868805518; zhuyirui001@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 15, 2024
• Study Start: August 8, 2024
• Primary Completion: August 31, 2024
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 15, 2024

Record last verified: 2024-08

Locations

CN (1)