Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04535388
Other study ID # LK Scleral Lens
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2012
Est. completion date April 22, 2014

Study information

Verified date August 2020
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date April 22, 2014
Est. primary completion date March 31, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 69 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04067973 - Impact of Prematurity on the Optic Nerve
Completed NCT04828057 - Preservative-free Fixed-dose Combination of Tafluprost 0.0015% / Timolol 0.5% in Patients With Open-angle Glaucoma or Ocular Hypertension: Clinical Effectiveness, Tolerability and Safety in a Real World Setting
Not yet recruiting NCT06375343 - Study to Evaluating PRO-240 Ophthalmic Solution Compared to Optive® Phase 1
Completed NCT00346450 - Autologous ex Vivo Conjunctival Epithelial Cell Expansion for Ocular Surface Transplantation Phase 3
Completed NCT04351100 - Efficacy of Diacerein on Ocular Surface Disease in Degenerative Arthritis Patients
Completed NCT03659955 - Autologous Blood Treatment for Ocular Surface Disease N/A
Completed NCT04536129 - Effects of Topical Low Dose Preservative-free Hydrocortisone on Intraocular Pressure N/A
Completed NCT01254370 - Safety and Efficacy Study of Catioprost® (Unpreserved Latanoprost 0.005% Emulsion) Compared to Travatan Z® to Treat Glaucoma and Ocular Surface Disease Phase 2
Completed NCT00554411 - Assessing Ocular Surface Changes After Changing Glaucoma Medications N/A
Completed NCT03769454 - A Phase I Study of PP-001 Eye Drops in Healthy Adult Volunteers Phase 1
Recruiting NCT06256770 - Evaluation of the Safety and Efficacy of Rigid Breathable Scleral Contact Lenses for the Correction of Ametropia
Completed NCT04673604 - From Preserved, to Preservative-free Cyclosporine 0.1% Enhanced Triple Glaucoma Therapy N/A
Not yet recruiting NCT06370585 - Clinical Study to Evaluate the Safety and Tolerability of PRO-229 Ophthalmic Solution Compared to Lagricel® Ofteno PF Phase 1
Withdrawn NCT04735510 - Novel Use of Restasis and PROSE Devices Phase 3
Suspended NCT00348114 - Transplantation of Cultivated Limbal Epithelium on Amniotic Membrane for Limbal Stem Cell Deficiency Phase 2
Recruiting NCT04010422 - Ocular Function in Autism Spectrum Disorder
Completed NCT05528016 - Short and Long-term Results of Skin Versus Skin Plus Orbicularis Resection Blepharoplasty N/A
Completed NCT04452279 - Ocular Surface Disease Changes After iStent or iStent Inject Implantation With Phacoemulsification N/A
Recruiting NCT06298890 - The Pattern of Dry Eye Disease After Cataract Surgery
Completed NCT02802137 - 24-hour Efficacy and Ocular Surface With Talfuprost and Triple Combined Therapy Phase 4