Epi-LASIK : A Confocal Microscopy Analysis of the Corneal Epithelium and Anterior Stroma.
This study has been completed.
Sponsor:
Asociación para Evitar la Ceguera en México
Information provided by:
Asociación para Evitar la Ceguera en México
ClinicalTrials.gov Identifier:
NCT00599690
First received: January 8, 2008
Last updated: January 28, 2008
Last verified: November 2007
| Tracking Information | |||||
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| First Received Date ICMJE | January 8, 2008 | ||||
| Last Updated Date | January 28, 2008 | ||||
| Start Date ICMJE | January 2006 | ||||
| Primary Completion Date | January 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
A central scan of the total corneal thickness was taken with the confocal microscope (Confoscan 4, Fortune Technologies, Italy) [ Time Frame: Before and at 2 weeks and 1 month after surgery ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00599690 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
There are no secondary outcome measures specified for this study [ Time Frame: There are no secondary outcome measures specified for this study ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Epi-LASIK : A Confocal Microscopy Analysis of the Corneal Epithelium and Anterior Stroma. | ||||
| Official Title ICMJE | Epi-LASIK : A Confocal Microscopy Analysis of the Corneal Epithelium and Anterior Stroma. | ||||
| Brief Summary | To evaluate the confocal microscopy findings at the corneal epithelium and anterior stroma after epi-LASIK Surgery. |
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| Detailed Description | 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). |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Screening |
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| Condition ICMJE | Corneal Epithelium | ||||
| Intervention ICMJE | 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 |
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| Study Arm (s) | Experimental: A
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
Intervention: Procedure: Epi-LASK |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 10 | ||||
| Completion Date | September 2007 | ||||
| Primary Completion Date | January 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Mexico | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00599690 | ||||
| Other Study ID Numbers ICMJE | Cornea 3 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Asociación para Evitar la Ceguera en México | ||||
| Study Sponsor ICMJE | Asociación para Evitar la Ceguera en México | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Asociación para Evitar la Ceguera en México | ||||
| Verification Date | November 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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