Automated Lamellar Keratectomy in Symptomatic Patients With Bullous Keratopathy

Corneal Disease Clinical Trial

— ALKSBK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654888
• Other study ID #: 0068/05
• Status: Completed
• Phase: N/A
• First received: April 3, 2008
• Last updated: April 10, 2008
• Start date: March 2005
• Est. completion date: February 2008

Study information

• Verified date: April 2008
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 2008
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

Inclusion Criteria:

• Patient with bullous keratopathy symptomatic (with pain)

Exclusion Criteria:

• herpetic endotelial disorders

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Corneal Disease
• Corneal Diseases

Intervention

Procedure:
• ALK (automated lamellar keratectomy)
ALK is performed with a microkeratome, to make a free cap.

Drug:
• Mitomycin
mitomycin 0,02%, 30 seconds after ALK

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain questionnaire		preoperative and postoperative 1,7,30,90,180 days and one year	Yes
Secondary	biomicroscopy, esthesiometry, UBM pachymetry, impression cytology		preoperative, postoperative 1,7,30,90,180 days and one year	Yes