Ocular Surface DiseaseNCT04535388
LK Scleral Lens for Patients With Intractable Ocular Surface Diseases
A study testing LK scleral lens in people with Ocular Surface Disease, run by Seoul National University Hospital.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Ocular Surface Disease
- What is being tested?
- LK scleral lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2012to 22 Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Ocular Surface Disease
- Being tested
- LK scleral lens
- Keywords
- Cornea, LK scleral lens, Ocular surface disease, Scleral lens
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LK scleral lensDevice
LK scleral lens fitting and application were done for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| LK scleral lens | Other | LK scleral lens (Lucid Korea LTD, Seoul, Republic of Korea) are worn for 12 weeks. Receives: Device: LK scleral lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of visual improvement after wearing the LK scleral lens
Best corrected visual acuity is measured. Snellen visual acuity is converted to log of the Minimum Angle of Resolution for assessment.
Measured: Change from baseline best corrected visual acuity at week 1
Change of visual improvement after wearing the LK scleral lens
Best corrected visual acuity is measured. Snellen visual acuity is converted to log of the Minimum Angle of Resolution for assessment.
Measured: Change from baseline best corrected visual acuity at week 4
Change of visual improvement after wearing the LK scleral lens
Best corrected visual acuity is measured. Snellen visual acuity is converted to log of the Minimum Angle of Resolution for assessment.
Measured: Change from baseline best corrected visual acuity at week 8
Change of visual improvement after wearing the LK scleral lens
Best corrected visual acuity is measured. Snellen visual acuity is converted to log of the Minimum Angle of Resolution for assessment.
Measured: Change from baseline best corrected visual acuity at week 12
Change of ocular surface state after wearing the LK scleral lens
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.
Measured: Change from baseline ocular surface state at week 1
Change of ocular surface state after wearing the LK scleral lens
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.
Measured: Change from baseline ocular surface state at week 4
Change of ocular surface state after wearing the LK scleral lens
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.
Measured: Change from baseline ocular surface state at week 8
Change of ocular surface state after wearing the LK scleral lens
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.
Measured: Change from baseline ocular surface state at week 12
Change of subjective ocular surface discomfort after wearing the LK scleral lens
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.
Measured: Change from baseline 25-Item Visual Function Questionnaire scores at week 1
Change of subjective ocular surface discomfort after wearing the LK scleral lens
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.
Measured: Change from baseline 25-Item Visual Function Questionnaire scores at week 4
Change of subjective ocular surface discomfort after wearing the LK scleral lens
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.
Measured: Change from baseline 25-Item Visual Function Questionnaire scores at week 8
Change of subjective ocular surface discomfort after wearing the LK scleral lens
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.
Measured: Change from baseline 25-Item Visual Function Questionnaire scores at week 12
Change of subjective ocular surface discomfort after wearing the LK scleral lens
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.
Measured: Change from baseline ocular surface disease index at week 1
Change of subjective ocular surface discomfort after wearing the LK scleral lens
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.
Measured: Change from baseline ocular surface disease index at week 4
Change of subjective ocular surface discomfort after wearing the LK scleral lens
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.
Measured: Change from baseline ocular surface disease index at week 8
Change of subjective ocular surface discomfort after wearing the LK scleral lens
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.
Measured: Change from baseline ocular surface disease index at week 12
Adverse effects after wearing the LK scleral lens
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.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start1 May 2012
- Primary completion31 Mar 2014
- Study completion22 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ocular Surface DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535388
- Sponsor's protocol ID
- LK Scleral Lens
- Status last verified
- Aug 2020
- First submitted
- 18 Aug 2020
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moon J, Lee SM, Hyon JY, Kim MK, Oh JY, Choi HJ. Large diameter scleral lens benefits for Asians with intractable ocular surface diseases: a prospective, single-arm clinical trial. Sci Rep. 2021 Jan 27;11(1):2288. doi: 10.1038/s41598-021-82010-z.
PubMed 33504920
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of LK Scleral Lens for Patients With Intractable Ocular Surface Diseases: A Prospective, Multicenter, Open-Label, Single-Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT04535388
- Acronym / sponsor ID
- LK Scleral Lens
- Conditions
- Ocular Surface Disease
- Keywords
- Cornea, LK scleral lens, Ocular surface disease, Scleral lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 May 2012 (actual)
- Primary completion
- 31 Mar 2014 (actual)
- Study completion
- 22 Apr 2014 (actual)
- First posted
- 2 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LK scleral lens | Other | Device: LK scleral lensLK scleral lens (Lucid Korea LTD, Seoul, Republic of Korea) are worn for 12 weeks. |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LK scleral lensLK scleral lens fitting and application were done for 12 weeks. | Device | LK scleral lens |
Primary outcome
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 33504920Moon J, Lee SM, Hyon JY, Kim MK, Oh JY, Choi HJ. Large diameter scleral lens benefits for Asians with intractable ocular surface diseases: a prospective, single-arm clinical trial. Sci Rep. 2021 Jan 27;11(1):2288. doi: 10.1038/s41598-021-82010-z.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing LK scleral lens in people with Ocular Surface Disease, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of visual improvement after wearing the LK scleral lens (time frame: Change from baseline best corrected visual acuity at week 1). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04535388, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.