Clinical trial NCT04535388: LK Scleral Lens for Patients With Intractable Ocular Surface Diseases
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ocular Surface Disease
Keywords: Cornea
LK scleral lens
Ocular surface disease
Scleral lens
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of visual improvement after wearing the LK scleral lens
timeFrame: Change from baseline best corrected visual acuity at week 1
measure: Change of visual improvement after wearing the LK scleral lens
timeFrame: Change from baseline best corrected visual acuity at week 4
measure: Change of visual improvement after wearing the LK scleral lens
timeFrame: Change from baseline best corrected visual acuity at week 8
measure: Change of visual improvement after wearing the LK scleral lens
timeFrame: Change from baseline best corrected visual acuity at week 12
measure: Change of ocular surface state after wearing the LK scleral lens
timeFrame: Change from baseline ocular surface state at week 1
measure: Change of ocular surface state after wearing the LK scleral lens
timeFrame: Change from baseline ocular surface state at week 4
measure: Change of ocular surface state after wearing the LK scleral lens
timeFrame: Change from baseline ocular surface state at week 8
measure: Change of ocular surface state after wearing the LK scleral lens
timeFrame: Change from baseline ocular surface state at week 12
measure: Change of subjective ocular surface discomfort after wearing the LK scleral lens
timeFrame: Change from baseline 25-Item Visual Function Questionnaire scores at week 1
measure: Change of subjective ocular surface discomfort after wearing the LK scleral lens
timeFrame: Change from baseline 25-Item Visual Function Questionnaire scores at week 4
measure: Change of subjective ocular surface discomfort after wearing the LK scleral lens
timeFrame: Change from baseline 25-Item Visual Function Questionnaire scores at week 8
measure: Change of subjective ocular surface discomfort after wearing the LK scleral lens
timeFrame: Change from baseline 25-Item Visual Function Questionnaire scores at week 12
measure: Change of subjective ocular surface discomfort after wearing the LK scleral lens
timeFrame: Change from baseline ocular surface disease index at week 1
measure: Change of subjective ocular surface discomfort after wearing the LK scleral lens
timeFrame: Change from baseline ocular surface disease index at week 4
measure: Change of subjective ocular surface discomfort after wearing the LK scleral lens
timeFrame: Change from baseline ocular surface disease index at week 8
measure: Change of subjective ocular surface discomfort after wearing the LK scleral lens
timeFrame: Change from baseline ocular surface disease index at week 12
measure: Adverse effects after wearing the LK scleral lens
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.