Keratoconus Clinical Trial
Official title:
Comparison of Epi-off and Epi-on Photorefractive Intrastromal Crosslinking (PiXL) for Progressive Keratoconus
NCT number | NCT03990506 |
Other study ID # | PiXLKC-I |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2, 2019 |
Est. completion date | January 24, 2023 |
Verified date | August 2023 |
Source | Umeå University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the efficacy, safety and postoperative ocular discomfort by comparing individually customized Photorefractive intrastromal crosslinking (PiXL) for progressive Keratoconus. The study compares two different protocols, PiXL with corneal epithelium debridement (Epi-off) and PiXL without epithelium debridement in high oxygen environment (Epi-on), with the hypothesis that Epi-on gives less postoperative ocular discomfort.
Status | Completed |
Enrollment | 32 |
Est. completion date | January 24, 2023 |
Est. primary completion date | January 24, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria: - Patients planned for corneal crosslinking. - Progressive keratoconus documented with a consistent decrease of best corrected visual acuity with no other explanation, an unquestionable historical progression, or a progression documented with the Pentacam Scheimpflug camera with at least 2 of the following: progressive anterior and/or posterior corneal steepening and/or progressive corneal thinning and/or increased rate of corneal thickness change from the periphery to the center. - A keratoconus diagnosis based on abnormal posterior elevation, abnormal corneal thickness distribution and clinical noninflammatory corneal thinning using the "Belin/Ambrósio enhanced ectasia" measurements of the Pentacam Scheimpflug camera. - Minimum corneal thickness of 400 µm at the thinnest point before epithelial removal. - 18-35 years of age - No ocular abnormalities except keratoconus - No previous ocular surgery - No cognitive insufficiency interfering with the informed consent. Exclusion Criteria: - Age under 18 or over 35 - Any corneal abnormalities except keratoconus - Pregnancy or lactation - Previous ocular surgery - Cognitive insufficiency |
Country | Name | City | State |
---|---|---|---|
Sweden | Department of Clinical Sciences/Ophthalmology, Umeå University | Umeå |
Lead Sponsor | Collaborator |
---|---|
Umeå University | Glaukos Corporation |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximal keratometry (Kmax) | Kmax assessed with the Pentacam HR Scheimpflug camera, Diopters. | 1 month, 3 months, 6 months, 12 months and 24 months after treatment | |
Secondary | Uncorrected distance visual acuity (UDVA) | Change from baseline in distance uncorrected visual acuity, LogMAR | 1 month, 3 months, 6 months, 12 months and 24 months after treatment | |
Secondary | Best corrected visual acuity (BCVA) | Change from baseline in distance best corrected visual acuity, LogMAR | 1 month, 3 months, 6 months, 12 months and 24 months after treatment | |
Secondary | Mean keratometry (Kmean) | Kmean (average) assessed with the Pentacam HR Scheimpflug camera, Diopters. | 1 month, 3 months, 6 months, 12 months and 24 months after treatment | |
Secondary | Subjective Ocular Discomfort Scores | Subjective Ocular Discomfort Scores, Visual Analog Score (0 (no discomfort) - 10 (maximum discomfort)) for each eye, mm. | 4 hours, 8 hours, 1 day, 2 days, 3 days, 4 days, 5 days, 6 days and 7 days after treatment | |
Secondary | Low contrast visual acuity (LCVA) | Change from baseline in low contrast visual acuities at 10 % and 2.5 % contrast, LogMAR | 1 month, 3 months, 6 months, 12 months and 24 months after treatment | |
Secondary | Manifest spherical equivalent (MRSE) | Change from baseline in spherical equivalent on subjective distance refraction, Diopters | 1 month, 3 months, 6 months, 12 months and 24 months after treatment | |
Secondary | Central corneal thickness (CCT) | Change from baseline in central corneal thickness assessed with Pentacam, Scheimpflug camera, µm. | 1 month, 3 months, 6 months, 12 months and 24 months after treatment | |
Secondary | Change from baseline in ocular wavefront aberrometry | Change from baseline in higher order aberrations assessed with iTrace, Root mean square. | 1 month, 3 months, 6 months, 12 months and 24 months after treatment | |
Secondary | Endothelial cell density (ECC) | Change from baseline in endothelial cell density, cells/mm2 | 24 months after treatment | |
Secondary | Intraocular pressure (IOP) | Change from baseline in intraocular pressure assessed with Goldmann applanation tonometry, mmHg. | 1 month, 3 months, 6 months, 12 months and 24 months after treatment |
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