Ocular Surface Disease Clinical Trial
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
Verified date | August 2020 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
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 |
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 |