NCT04535388

Brief 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 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2014

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2014

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

August 18, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 2, 2020

Completed
Last Updated

October 8, 2020

Status Verified

August 1, 2020

Enrollment Period

1.9 years

First QC Date

August 18, 2020

Last Update Submit

October 5, 2020

Conditions

Ocular Surface Disease

Keywords

CorneaLK scleral lensOcular surface diseaseScleral lens

Outcome Measures

Primary Outcomes (17)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    Week 12

Study Arms (1)

LK scleral lens

OTHER

LK scleral lens (Lucid Korea LTD, Seoul, Republic of Korea) are worn for 12 weeks.

Device: LK scleral lens

Interventions

LK scleral lensDEVICE

LK scleral lens fitting and application were done for 12 weeks.

LK scleral lens

Eligibility Criteria

Age20 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 33504920DERIVED

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2020

First Posted

September 2, 2020

Study Start

May 1, 2012

Primary Completion

March 31, 2014

Study Completion

April 22, 2014

Last Updated

October 8, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share