Automated Lamellar Keratectomy in Symptomatic Patients With Bullous Keratopathy

Federal University of São Paulo28 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Corneal Disease

Interventions

ALK (automated lamellar keratectomy)PROCEDURE

ALK is performed with a microkeratome, to make a free cap.

MitomycinDRUG

mitomycin 0,02%, 30 seconds after ALK

Eligibility

Sex: ALLMin age: 10 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient with bullous keratopathy symptomatic (with pain) Exclusion Criteria: * herpetic endotelial disorders

Outcomes

Primary Outcomes

Pain questionnaire

Time frame: preoperative and postoperative 1,7,30,90,180 days and one year

Secondary Outcomes

biomicroscopy, esthesiometry, UBM pachymetry, impression cytology

Time frame: preoperative, postoperative 1,7,30,90,180 days and one year

Data from ClinicalTrials.gov

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