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| Sponsor: | Asociación para Evitar la Ceguera en México |
|---|---|
| Information provided by: | Asociación para Evitar la Ceguera en México |
| ClinicalTrials.gov Identifier: | NCT00599690 |
Purpose
To evaluate the confocal microscopy findings at the corneal epithelium and anterior stroma after epi-LASIK Surgery.
| Condition | Intervention |
|---|---|
|
Corneal Epithelium |
Procedure: Epi-LASK |
| Study Type: | Interventional |
| Study Design: | Screening, Open Label, Uncontrolled, Single Group Assignment |
| Official Title: | Epi-LASIK : A Confocal Microscopy Analysis of the Corneal Epithelium and Anterior Stroma. |
| Enrollment: | 10 |
| Study Start Date: | January 2006 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Epithelial flaps were created with the Amadeus II, epi-LASIK-LASIK microkeratome (Ziemer ophthalmics systems AG, Switzerland). A Visx star 4 system (Visx, Santa Ana, CA, USA) was used to perform the laser ablation in all eyes
|
Procedure: Epi-LASK
10 eyes of 10 patients underwent epi-LASK, epithelial flaps were created with the Amadeus II, epi-LASIK-LASIK microkeratome (Ziemer ophthalmics systems AG, Switzerland). A Visx star 4 system (Visx, Santa Ana, CA, USA) was used to perform the laser ablation in all eyes
|
10 eyes of 10 patients underwent epi-LASK, epithelial flaps were created with the Amadeus II, epi-LASIK-LASIK microkeratome (Ziemer ophthalmics systems AG, Switzerland). A Visx star 4 system (Visx, Santa Ana, CA, USA) was used to perform the laser ablation in all eyes. A central scan of the total corneal thickness was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy) before and at 2 weeks and 1 month after surgery. Corneal epithelial thickness and the Anterior stroma morphology were analyzed by using the NAVIS software V. 3.5.0 (NIDEK, Multi-Instrument Diagnostic System, Japan).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Mexico, Distrito Federal | |
| Asociación Para Evitar la Ceguera en Mëxico, Hospital "Luis Sánchez Bulnes". | |
| Mexico city, Distrito Federal, Mexico, 04030 | |
| Principal Investigator: | Ramirez F Manuel, MD | APEC |
More Information
| Responsible Party: | Asociación para Evitar la Ceguera en México ( Asociación para Evitar la Ceguera en México ) |
| Study ID Numbers: | Cornea 3, No |
| Study First Received: | January 8, 2008 |
| Last Updated: | January 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00599690 History of Changes |
| Health Authority: | Mexico: Ethics Committee |
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Epi-LASIK-LASIK microkeratome Corneal thickness Confocal microscope |