Automated Lamellar Keratectomy in Symptomatic Patients With Bullous Keratopathy (ALKSBK)

April 10, 2008 updated by: Federal University of São Paulo

Study of Automated Lamellar Keratectomy With a New Option in Treatment in Symptomatic Patients With Bullous Keratopathy.

To relieve pain in patients with symptomatic bullous keratopathy (BK) until keratoplasty and in patients without visual prediction.

The automated lamellar keratectomy represents a alternative in treatment of pain in symptomatic patients with BK.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Only patients with BK symptomatic (with pain) were submitted to automated lamellar keratectomy (ALK).

Complete ophthalmological examination including UCVA,BSVA, biomicroscopy, tonometry, esthesiometry, UBM pachymetry, impression cytology and pain questionnaire were performed in preoperative, postoperative of one, seven, 30, 90, 180 days and one year.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

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

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with bullous keratopathy symptomatic (with pain)

Exclusion Criteria:

  • herpetic endotelial disorders

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Group one submitted to automated lamellar keratectomy(ALK) with mitomycin (0,02% in 30 seconds after keratectomy).
Drug: Mitomycin
mitomycin 0,02%, 30 seconds after ALK
Other Names:
  • automated lamellar keratectomy associated with PTK
Active Comparator: 2
automated lamellar keratectomy without mitomycin
Procedure: ALK (automated lamellar keratectomy)
ALK is performed with a microkeratome, to make a free cap.
Other Names:
  • automated lamellar keratectomy with PTK

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain questionnaire
Time Frame: preoperative and postoperative 1,7,30,90,180 days and one year
preoperative and postoperative 1,7,30,90,180 days and one year

Secondary Outcome Measures

Outcome Measure
Time Frame
biomicroscopy, esthesiometry, UBM pachymetry, impression cytology
Time Frame: preoperative, postoperative 1,7,30,90,180 days and one year
preoperative, postoperative 1,7,30,90,180 days and one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Eliana D Gonçalves, MD, Federal University of São Paulo

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

March 1, 2005

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

April 3, 2008

First Submitted That Met QC Criteria

April 3, 2008

First Posted (Estimate)

April 9, 2008

Study Record Updates

Last Update Posted (Estimate)

April 11, 2008

Last Update Submitted That Met QC Criteria

April 10, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0068/05

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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