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Completed

NCT Number: NCT04535388

LK Scleral Lens for Patients With Intractable Ocular Surface Diseases

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.

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Key information

Conditions

Ocular Surface Disease Corneal Diseases Eye Diseases

Age range

20 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LK scleral lens

Device

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  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.

  9. 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.

  10. 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.

  11. 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.

  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 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Sep 2, 2020
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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