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The goal of this clinical trial is to document corneal ectasia stability in patients with keratoconus diagnosis treated with personalized cross linking energy. The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized cross linking | Experimental | Participants were treated with personalized energy cross linking according to their thinnest point corneal pachymetry |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corneal Cross Linking | Procedure | Total fluence adapted to thinnest point pachymetry |
|
| Measure | Description | Time Frame |
|---|---|---|
| Keratometry stability | Stability documented by changes in keratometries (measured in diopters) obtained with corneal tomography, as well as uncorrected visual acuity observed in follow up consults | Baseline and 6 months |
| Pachymetry stability | Stability documented by changes in pachymetry (measured in microns) obtained with corneal tomography | Baseline and 6 months |
| Uncorrected visual acuity stability | Stability documented by changes in uncorrected visual acuity (measured in logarithm of the minimum angle of resolution) obtained on physical examiantion | Baseline, 72 hours, 1 week, 3 months and 6 months |
| Corneal endothelium safety | Corneal endothelial cell count obtained by specular microscopy | Baseline, 72 hours, 1 week, 3 months and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Itamar Vigderovich, MD | Contact | +52 5519491905 | vigderovich@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Enrique Graue, MD, MSc | Instituto de OftalmologÃa Conde de Valenciana | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de OftalmologÃa Conde de Valenciana | Recruiting | Mexico City | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33340508 | Background | Hafezi F, Kling S, Gilardoni F, Hafezi N, Hillen M, Abrishamchi R, Gomes JAP, Mazzotta C, Randleman JB, Torres-Netto EA. Individualized Corneal Cross-linking With Riboflavin and UV-A in Ultrathin Corneas: The Sub400 Protocol. Am J Ophthalmol. 2021 Apr;224:133-142. doi: 10.1016/j.ajo.2020.12.011. Epub 2021 Jan 30. | |
| 30681515 | Background |
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| D018450 | Disease Progression |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000094504 | Corneal Cross-Linking |
| ID | Term |
|---|---|
| D010778 | Photochemotherapy |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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| Lang PZ, Hafezi NL, Khandelwal SS, Torres-Netto EA, Hafezi F, Randleman JB. Comparative Functional Outcomes After Corneal Crosslinking Using Standard, Accelerated, and Accelerated With Higher Total Fluence Protocols. Cornea. 2019 Apr;38(4):433-441. doi: 10.1097/ICO.0000000000001878. |
| 33383093 | Background | Nath S, Shen C, Koziarz A, Banfield L, Nowrouzi-Kia B, Fava MA, Hodge WG. Transepithelial versus Epithelium-off Corneal Collagen Cross-linking for Corneal Ectasia: A Systematic Review and Meta-analysis. Ophthalmology. 2021 Aug;128(8):1150-1160. doi: 10.1016/j.ophtha.2020.12.023. Epub 2020 Dec 28. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010789 |
| Phototherapy |