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The goal of this clinical trial is to compare CXL with combined treatment with CXL and t-PTK.
The main questions it aims to answer are whether combined treatment can give better visual acuity and if the treatments are equally safe.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CXL | Active Comparator | Treatment with CXL alone |
|
| CXL and t-PTK | Experimental | Treatment with t-PTK combined with CXL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corneal collagen cross linking (CXL) | Procedure | Use of Avedro Inc. KXL 1 system to stop progression of keratoconus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | Uncorrected and corrected distance visual acuity in logMAR | 1 month after surgery |
| Risk of progression | Change in keratometric values | 1 year after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | Uncorrected and corrected distance visual acuity in logMAR | 3 month after surgery |
| Visual acuity | Uncorrected and corrected distance visual acuity in logMAR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olav Kristianslund, MD, PhD | Contact | +4722118545 | olakri@ous-hf.no |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophhtalmology, University of Oslo | Recruiting | Oslo | Norway |
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| Transepithelial phototherapeutic keratectomy (t-PTK) | Procedure | Use Alcon Wavelight 500, excimer laser to remove the epithelium and some of the stroma over apex |
|
| 6 month after surgery |
| Visual acuity | Uncorrected and corrected distance visual acuity in logMAR | 1 year after surgery |
| Visual acuity | Uncorrected and corrected distance visual acuity in logMAR | 2 years after surgery |
| Visual acuity | Uncorrected and corrected distance visual acuity in logMAR | 5 years after surgery |
| Risk of progression | Change in keratometric values | 1 month after surgery |
| Risk of progression | Change in keratometric values | 3 months after surgery |
| Risk of progression | Change in keratometric values | 6 months after surgery |
| Risk of progression | Change in keratometric values | 2 years after surgery |
| Risk of progression | Change in keratometric values | 5 years after surgery |
| Depth of demarcation line (OCT) | Measured with corneal optical coherence tomography (OCT) | 1 month after surgery |
| Depth of demarcation line (confocal microscopy) | Measured with confocal microscopy | 1 month after surgery |
| Patient reported outcome measure (PROMs) | National eye institute Visual Function Questionnaire 25 | 1 month after surgery |
| Patient reported outcome measure (PROMs) | National eye institute Visual Function Questionnaire 25 | 6 months after surgery |
| Patient reported outcome measure (PROMs) | National eye institute Visual Function Questionnaire 25 | 2 years after surgery |
| Patient reported pain after surgery | Pain the first 48 hours after the surgery graded on visual analogue scale (VAS); 0 to 10 cm. | 48 hours after surgery |
| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000094504 | Corneal Cross-Linking |
| ID | Term |
|---|---|
| D010778 | Photochemotherapy |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |
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