Clinical Application Research of Scleral Lenses in Ocular Surface Diseases

August 13, 2024 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Second Affiliated Hospital of Zhejiang University Hospital
        • Principal Investigator:
          • lin lin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
scleral lenses group
The case group consists of patients with irregular corneas who wear scleral lenses.
Device: scleral lenses
Wear scleral lenses
control group
The control group comprises patients with irregular corneas who have not undergone treatment with scleral lenses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scleral lens fitting assessment
Time Frame: 4 hours later
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective comfort assessment
Time Frame: 4 hours later
Level 1: Very uncomfortable; Level 2: Uncomfortable; Level 3: Moderate comfort; Level 4: Comfortable; Level 5: Very comfortable.
4 hours later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 8, 2024

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2026

Study Registration Dates

First Submitted

August 13, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Actual)

August 15, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2024-0667

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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