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

Federal University of São Paulo

Status: Completed

Conditions: Corneal Disease

Treatments: Procedure: ALK (automated lamellar keratectomy); Drug: Mitomycin

Study type: Interventional

Funder types: Other

Identifiers

NCT00654888

0068/05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with bullous keratopathy symptomatic (with pain)

Exclusion criteria

• herpetic endotelial disorders

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

1

Active Comparator group

Description:

Group one submitted to automated lamellar keratectomy(ALK) with mitomycin (0,02% in 30 seconds after keratectomy).

Treatment:

Drug: Mitomycin

2

Active Comparator group

Description:

automated lamellar keratectomy without mitomycin

Treatment:

Procedure: ALK (automated lamellar keratectomy)