Epi-LASIK : A Confocal Microscopy Analysis of the Corneal Epithelium and Anterior Stroma.

Corneal Epithelium Clinical Trial

Official title:

Epi-LASIK : A Confocal Microscopy Analysis of the Corneal Epithelium and Anterior Stroma.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00599690
• Other study ID #: Cornea 3
• Status: Terminated
• Phase: N/A
• Start date: January 2006
• Est. completion date: September 2007

Study information

• Verified date: May 2024
• Source: Asociación para Evitar la Ceguera en México
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the confocal microscopy findings at the corneal epithelium and anterior stroma after epi-LASIK Surgery.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: September 2007
• Est. primary completion date: January 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Corneal Epithelium

Intervention

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

Locations

Country	Name	City	State
Mexico	Asociación Para Evitar la Ceguera en Mëxico, Hospital "Luis Sánchez Bulnes".	Mexico city	Distrito Federal

Sponsors (1)

Lead Sponsor	Collaborator
Asociación para Evitar la Ceguera en México

Country where clinical trial is conducted

Mexico, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	There are no secondary outcome measures specified for this study		There are no secondary outcome measures specified for this study