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
Not provided
The purpose of this study is to evaluate the visual results of patients with keratoconus treated with one of two techniques: penetrating keratoplasty (PK) vs. pachymetry and Excimer laser assisted lamellar keratoplasty (PALK).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Penetrating keratoplasty | Experimental | Conventional penetrating keratoplasty technique |
|
| PALK | Experimental | Pachymetry and Excimer laser assisted lamellar keratoplasty |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Penetrating keratoplasty | Procedure | Conventional Penetrating keratoplasty technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity | Uncorrected and corrected distance visual acuity | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal measurements: pachymetry | Evaluation of the pachymetric maps with a Scheimpflug-Placido device (Sirius). Measurement in microns | 6 months |
| Corneal aberrometry: Coma, spherical aberration and trefoil |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Enrique Graue Hernandez, MD, MsC | Instituto de Oftalmologia Conde de Valenciana | Study Director |
Not provided
Not provided
| ID | Term |
|---|---|
| D007640 | Keratoconus |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015948 | Keratoplasty, Penetrating |
| ID | Term |
|---|---|
| D016039 | Corneal Transplantation |
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Pachymetry and Excimer laser assisted lamellar keratoplasty | Procedure | Ablation profile focusing on topography and pachymetry with Schwind Amaris excimer laser |
|
| Treatment posterior to surgery | Drug | Fluoroquinolone topical antibiotic (Moxifloxacin, Vigamox) and topical steroid (Prednisolone Acetate Ophthalmic Suspension, Pred Forte) |
|
Evaluation of the corneal aberrations including coma, spherical aberration and trefoil, with a Scheimpflug-Placido device (Sirius)
| 6 months |
| Corneal measurements: anterior and posterior elevation | Evaluation of the elevation (anterior and posterior), maps with a Scheimpflug-Placido device (Sirius). Measurement in diopters | 6 months |
| Corneal measurements: keratometries. | Evaluation of the keratometric map with a Scheimpflug-Placido device (Sirius). Measurement in diopters | 6 months |
| D013812 | Therapeutics |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D014180 | Transplantation |