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

May 29, 2024 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

Status

Terminated

Conditions

Intervention / Treatment

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

  • Mexico
    • 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

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
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

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.

Sponsor

Asociación para Evitar la Ceguera en México

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

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 (Estimated)

January 24, 2008

Study Record Updates

Last Update Posted (Actual)

May 30, 2024

Last Update Submitted That Met QC Criteria

May 29, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

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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