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insufficient efficacy
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| Name | Class |
|---|---|
| Cornea Research Foundation of America | OTHER |
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This study is comparing 45 minute and 30 minute treatment durations with the UVX corneal cross linking system to treat corneal infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 minute light duration | Active Comparator | 30 minute treatment with UVX light |
|
| 45 minute light duration | Active Comparator | 45 minute treatment with UVX light |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| riboflavin | Drug | riboflavin 0.1% is applied every 2 minutes for 30 minutes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Re-epithelialization | Day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until re-epithelialization is complete |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Resolution of Stromal Infiltration | day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until infiltrate is completely resolved |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francis W Price, MD | Price Vision Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Price Vision Group | Indianapolis | Indiana | 46260 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18520510 | Background | Iseli HP, Thiel MA, Hafezi F, Kampmeier J, Seiler T. Ultraviolet A/riboflavin corneal cross-linking for infectious keratitis associated with corneal melts. Cornea. 2008 Jun;27(5):590-4. doi: 10.1097/ICO.0b013e318169d698. | |
| 23062001 | Result | Price MO, Tenkman LR, Schrier A, Fairchild KM, Trokel SL, Price FW Jr. Photoactivated riboflavin treatment of infectious keratitis using collagen cross-linking technology. J Refract Surg. 2012 Oct;28(10):706-13. doi: 10.3928/1081597X-20120921-06. |
| Label | URL |
|---|---|
| Price Vision Group website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 30 Minute Light Duration | 30 minute treatment with UVX light riboflavin: riboflavin 0.1% is applied every 2 minutes for 30 minutes UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1% |
| FG001 | 45 Minute Light Duration | 45 minute treatment with UVX light UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1% |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This is the number of participants who were culture-positive
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| ID | Title | Description |
|---|---|---|
| BG000 | 30 Minute Light Duration | 30 minute treatment with UVX light riboflavin: riboflavin 0.1% is applied every 2 minutes for 30 minutes UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1% |
| BG001 | 45 Minute Light Duration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Re-epithelialization | Posted | Median | Inter-Quartile Range | Days | Day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until re-epithelialization is complete |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 30 Minute Light Duration | 30 minute treatment with UVX light UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1% |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cornea transplant | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marianne O. Price, PhD | Cornea Research Foundation of America | 317-814-2990 | mprice@cornea.org |
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| ID | Term |
|---|---|
| D003320 | Corneal Ulcer |
| ID | Term |
|---|---|
| D015817 | Eye Infections |
| D007239 | Infections |
| D007634 | Keratitis |
| D003316 | Corneal Diseases |
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| ID | Term |
|---|---|
| D012256 | Riboflavin |
| ID | Term |
|---|---|
| D005415 | Flavins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| UVX Light |
| Device |
UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1% |
|
| 32557558 | Derived | Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2. |
45 minute treatment with UVX light riboflavin: riboflavin 0.1% is applied every 2 minutes for 30 minutes UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1% |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Time to Resolution of Stromal Infiltration | Posted | Median | Inter-Quartile Range | days | day 1, day 2, day 3, day 4, day 5, day 6, day 7, week 2, and subsequent weekly assessments until infiltrate is completely resolved |
|
|
|
| 0 |
| 20 |
| 5 |
| 20 |
| EG001 | 45 Minute Light Duration | 45 minute treatment with UVX light UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1% | 0 | 10 | 4 | 10 |
| Intracorneal injection of voriconazole | Eye disorders | Systematic Assessment |
|
| Dendritic lesions characteristic of prior herpes simplex | Eye disorders |
|
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| D005128 |
| Eye Diseases |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |