LK Scleral Lens for Patients With Intractable Ocular Surface Diseases

October 5, 2020 updated by: Seoul National University Hospital

Efficacy and Safety of LK Scleral Lens for Patients With Intractable Ocular Surface Diseases: A Prospective, Multicenter, Open-Label, Single-Arm Clinical Trial

Scleral lenses have emerged as an efficacious treatment option for various types of intractable ocular surface diseases with many advantageous results. The purpose of this study was to report the efficacy and safety of the LK scleral lenses and determine their suitability in Asian patients with intractable ocular surface diseases. Subjects with intractable ocular surface diseases are enrolled to fit LK scleral lenses for 12 weeks for a prospective study. Evaluations are performed at 1, 4, 8 and 12 weeks. General patient demographics and medical history, visual acuities, thorough ophthalmic evaluation, ocular surface disease index and National Eye Institute 25-Item Visual Function Questionnaire are collected for each patient.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To date, there are several commercially manufactured scleral lenses of different designs and sizes, all of which have been proven to be clinically beneficial in a wide spectrum of diseases. Especially in the management of intractable ocular surface diseases, scleral lenses with large diameters are commonly used so that the lens entirely rests on the sclera with sufficient tear reservoir. PROSE devices (Boston Foundation for Sight, Needham, MA), one of the first and representative scleral lenses shown to have long-term clinical benefits for complex corneal diseases, have large diameters of 17.5 to 23.0 mm. However, in Republic of Korea, only scleral lenses with small diameters are currently available. SoClearⓇ and OnefitⓇ scleral lenses, two of the most commonly used scleral lenses in Republic of Korea, possess diameters ranging from 14.1 to 15.5 mm and 13.3 to 15.0 mm, respectively, and are not actually fully scleral but more of a corneoscleral type lenses. Furthermore, Asians have smaller palpebral fissures with tighter eyelids than the Western population, which may restrict patients' tolerability of wearing a large scleral lens and limit its clinical benefits. Therefore, a more suitable scleral lens for Asians with larger diameter is required.

Accordingly, this study investigates the efficacy and safety of the LK scleral lens (Lucid Korea LTD, Seoul, Republic of Korea), which has been newly manufactured to have larger diameters than currently available commercial lenses, and determines their suitability in Asian patients with intractable ocular surface diseases.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 20 to 69 years
  • Intractable ocular surface disease
  • Uncorrected visual acuity better than count finger and ≥ 0.3 logMAR (log of the Minimum Angle of Resolution)
  • Best-corrected visual acuity ≥ 0.3 logMAR (log of the Minimum Angle of Resolution)

Exclusion Criteria:

  • Currently under treatment for infectious keratitis
  • Difficulty of scleral lens application due to severe allergic conjunctivitis, low compliance, and other potential contraindications
  • Diabetes mellitus and/or hypertension
  • Pregnant or planning pregnancy E. Unwilling to follow study schedule F. Enrolled in another clinical study G. Determined inappropriate under investigators' discretion

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: LK scleral lens
LK scleral lens (Lucid Korea LTD, Seoul, Republic of Korea) are worn for 12 weeks.
Device: LK scleral lens
LK scleral lens fitting and application were done for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of visual improvement after wearing the LK scleral lens
Time Frame: Change from baseline best corrected visual acuity at week 1
Best corrected visual acuity is measured. Snellen visual acuity is converted to log of the Minimum Angle of Resolution for assessment.
Change from baseline best corrected visual acuity at week 1
Change of visual improvement after wearing the LK scleral lens
Time Frame: Change from baseline best corrected visual acuity at week 4
Best corrected visual acuity is measured. Snellen visual acuity is converted to log of the Minimum Angle of Resolution for assessment.
Change from baseline best corrected visual acuity at week 4
Change of visual improvement after wearing the LK scleral lens
Time Frame: Change from baseline best corrected visual acuity at week 8
Best corrected visual acuity is measured. Snellen visual acuity is converted to log of the Minimum Angle of Resolution for assessment.
Change from baseline best corrected visual acuity at week 8
Change of visual improvement after wearing the LK scleral lens
Time Frame: Change from baseline best corrected visual acuity at week 12
Best corrected visual acuity is measured. Snellen visual acuity is converted to log of the Minimum Angle of Resolution for assessment.
Change from baseline best corrected visual acuity at week 12
Change of ocular surface state after wearing the LK scleral lens
Time Frame: Change from baseline ocular surface state at week 1
0.5% Fluorescein application to the ocular surface and observation under blue light exhibits ocular surface epithelial erosions that are associated with chronic dry eyes and irregular tear film status. Grading is performed through Oxford Grading which ranges from 0 = none to 5 = severe.
Change from baseline ocular surface state at week 1
Change of ocular surface state after wearing the LK scleral lens
Time Frame: Change from baseline ocular surface state at week 4
0.5% Fluorescein application to the ocular surface and observation under blue light exhibits ocular surface epithelial erosions that are associated with chronic dry eyes and irregular tear film status. Grading is performed through Oxford Grading which ranges from 0 = none to 5 = severe.
Change from baseline ocular surface state at week 4
Change of ocular surface state after wearing the LK scleral lens
Time Frame: Change from baseline ocular surface state at week 8
0.5% Fluorescein application to the ocular surface and observation under blue light exhibits ocular surface epithelial erosions that are associated with chronic dry eyes and irregular tear film status. Grading is performed through Oxford Grading which ranges from 0 = none to 5 = severe.
Change from baseline ocular surface state at week 8
Change of ocular surface state after wearing the LK scleral lens
Time Frame: Change from baseline ocular surface state at week 12
0.5% Fluorescein application to the ocular surface and observation under blue light exhibits ocular surface epithelial erosions that are associated with chronic dry eyes and irregular tear film status. Grading is performed through Oxford Grading which ranges from 0 = none to 5 = severe.
Change from baseline ocular surface state at week 12
Change of subjective ocular surface discomfort after wearing the LK scleral lens
Time Frame: Change from baseline 25-Item Visual Function Questionnaire scores at week 1
25-Item Visual Function Questionnaire scores is a validated self-reporting dry eye symptom questionnaires. The scores are graded from 0 = no symptoms to 100 = all symptoms with the most severity.
Change from baseline 25-Item Visual Function Questionnaire scores at week 1
Change of subjective ocular surface discomfort after wearing the LK scleral lens
Time Frame: Change from baseline 25-Item Visual Function Questionnaire scores at week 4
25-Item Visual Function Questionnaire scores is a validated self-reporting dry eye symptom questionnaires. The scores are graded from 0 = no symptoms to 100 = all symptoms with the most severity.
Change from baseline 25-Item Visual Function Questionnaire scores at week 4
Change of subjective ocular surface discomfort after wearing the LK scleral lens
Time Frame: Change from baseline 25-Item Visual Function Questionnaire scores at week 8
25-Item Visual Function Questionnaire scores is a validated self-reporting dry eye symptom questionnaires. The scores are graded from 0 = no symptoms to 100 = all symptoms with the most severity.
Change from baseline 25-Item Visual Function Questionnaire scores at week 8
Change of subjective ocular surface discomfort after wearing the LK scleral lens
Time Frame: Change from baseline 25-Item Visual Function Questionnaire scores at week 12
25-Item Visual Function Questionnaire scores is a validated self-reporting dry eye symptom questionnaires. The scores are graded from 0 = no symptoms to 100 = all symptoms with the most severity.
Change from baseline 25-Item Visual Function Questionnaire scores at week 12
Change of subjective ocular surface discomfort after wearing the LK scleral lens
Time Frame: Change from baseline ocular surface disease index at week 1
Ocular surface disease index is validated self-reporting dry eye symptom questionnaires. The scores are graded from 0 = no symptoms to 48 = all symptoms with the most severity.
Change from baseline ocular surface disease index at week 1
Change of subjective ocular surface discomfort after wearing the LK scleral lens
Time Frame: Change from baseline ocular surface disease index at week 4
Ocular surface disease index is validated self-reporting dry eye symptom questionnaires. The scores are graded from 0 = no symptoms to 48 = all symptoms with the most severity.
Change from baseline ocular surface disease index at week 4
Change of subjective ocular surface discomfort after wearing the LK scleral lens
Time Frame: Change from baseline ocular surface disease index at week 8
Ocular surface disease index is validated self-reporting dry eye symptom questionnaires. The scores are graded from 0 = no symptoms to 48 = all symptoms with the most severity.
Change from baseline ocular surface disease index at week 8
Change of subjective ocular surface discomfort after wearing the LK scleral lens
Time Frame: Change from baseline ocular surface disease index at week 12
Ocular surface disease index is validated self-reporting dry eye symptom questionnaires. The scores are graded from 0 = no symptoms to 48 = all symptoms with the most severity.
Change from baseline ocular surface disease index at week 12
Adverse effects after wearing the LK scleral lens
Time Frame: Week 12
Scleral lenses can cause endothelial cell density decrease and corneal edema. Endothelial cell density was assessed using a noncontact specular microscope, while corneal edema whereabouts was evaluating corneal thickness using ultrasound pachymetry.
Week 12

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 22, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 2, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 8, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LK Scleral Lens

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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