Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to determine the effectiveness and safety of corneal collagen cross-linking at irradiance levels of 9 and 18 mW/cm2.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 9 mW/cm2 | Active Comparator | CCL-VARIO UV lamp Riboflavin 0.1% ophthalmic solution |
|
| 18 mW/cm2 | Active Comparator | CCL-VARIO at 18 mW/cm2 Riboflavin 0.1% ophthalmic solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riboflavin 0.1% ophthalmic solution | Drug | Instillation of 0.1% riboflavin ophthalmic solution, one drop every 3 minutes for 30 minutes before the procedure and one drop every 3 minutes during the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in maximum corneal curvature | 3 and 6 months post-procedure |
Not provided
Not provided
General Inclusion Criteria
Prospective subjects must meet all of the following criteria to be eligible for participation:
Inclusion criteria for progressive keratoconus
Prospective subjects must meet two of the following criteria:
Inclusion criteria for ectasia
Prospective subjects must meet the following criteria:
Subjects meeting any of the following criteria will be excluded from this protocol:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert J Mack, M.D. | Contact | 847-755-9393 | rjsmack@aol.com |
| Name | Affiliation | Role |
|---|---|---|
| Robert J Mack, M.D. | Mack Eye Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mack Eye Center | Recruiting | Hoffman Estates | Illinois | 60169 | United States |
Not provided
| ID | Term |
|---|---|
| D007640 | Keratoconus |
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D012256 | Riboflavin |
| D009883 | Ophthalmic Solutions |
| D000081204 | Chromatin Immunoprecipitation Sequencing |
| ID | Term |
|---|---|
| D005415 | Flavins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| CCL-VARIO UV lamp | Device | Application of ultraviolet light on the eye to be treated at an irradiance of 9 mW/cm2 for 10 minutes |
|
|
| CCL-VARIO at 18 mW/cm2 | Device | Application of ultraviolet light on the eye to be treated at an irradiance of 18 mW/cm2 for 5 minutes. |
|
|
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D047369 | Chromatin Immunoprecipitation |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D059014 | High-Throughput Nucleotide Sequencing |
| D017421 | Sequence Analysis |
| D017422 | Sequence Analysis, DNA |
| D047468 | Immunoprecipitation |
| D007158 | Immunologic Techniques |