- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00599690
Epi-LASIK : A Confocal Microscopy Analysis of the Corneal Epithelium and Anterior Stroma.
January 28, 2008 updated by: Asociación para Evitar la Ceguera en México
To evaluate the confocal microscopy findings at the corneal epithelium and anterior stroma after epi-LASIK Surgery.
Study Overview
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).
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Distrito Federal
-
Mexico city, Distrito Federal, Mexico, 04030
- Asociación Para Evitar la Ceguera en Mëxico, Hospital "Luis Sánchez Bulnes".
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients asking for epi-LASIK surgery
- Patients with stable refraction in the last year
- Patients without systemic and ocular disease
- Patients with 500 microns in pachymetry
- Normal topography
Exclusion Criteria:
- Patients cannot attend their appointments
- Residual, recurrent or active ocular disease
- Previous ocular surgery except LASIK
- Autoimmune or connective tissue disease
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Before and at 2 weeks and 1 month after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
There are no secondary outcome measures specified for this study
Time Frame: There are no secondary outcome measures specified for this study
|
There are no secondary outcome measures specified for this study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ramirez F Manuel, MD, Asociación Para Evitar la Ceguera en México
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kollias A, Ulbig MW, Spitzlberger GM, Abdallat WH, Froehlich S, Welge-Luessen U, Lackerbauer CA. Epi-LASIK using the Amadeus II microkeratome: evaluation of cut quality using light and electron microscopy. J Cataract Refract Surg. 2007 Dec;33(12):2118-21. doi: 10.1016/j.jcrs.2007.07.038.
- Gamaly TO, El Danasoury A, El Maghraby A. A prospective, randomized, contralateral eye comparison of epithelial laser in situ keratomileusis and photorefractive keratectomy in eyes prone to haze. J Refract Surg. 2007 Nov;23(9 Suppl):S1015-20. doi: 10.3928/1081-597X-20071102-07.
- Katsanevaki VJ, Kalyvianaki MI, Kavroulaki DS, Pallikaris IG. One-year clinical results after epi-LASIK for myopia. Ophthalmology. 2007 Jun;114(6):1111-7. doi: 10.1016/j.ophtha.2006.08.052. Epub 2007 Feb 23.
- Hoang-Xuan T, Arnaud D, Souissi K, Cornu S. [Epi-LASIK, a novel surface photoablation technique]. J Fr Ophtalmol. 2007 May;30(5):535-8. doi: 10.1016/s0181-5512(07)89639-2. French.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2006
Primary Completion (Actual)
January 1, 2006
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
January 8, 2008
First Submitted That Met QC Criteria
January 23, 2008
First Posted (Estimate)
January 24, 2008
Study Record Updates
Last Update Posted (Estimate)
January 29, 2008
Last Update Submitted That Met QC Criteria
January 28, 2008
Last Verified
November 1, 2007
More Information
Terms related to this study
Other Study ID Numbers
- Cornea 3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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