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Automated Lamellar Keratectomy in Symptomatic Patients With Bullous Keratopathy

NCT ID: NCT00654888

Last Updated: 2008-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2008-02-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Corneal Disease

Keywords

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cataract extraction surgery corneal disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

Mitomycin

Intervention Type DRUG

mitomycin 0,02%, 30 seconds after ALK

2

automated lamellar keratectomy without mitomycin

Group Type ACTIVE_COMPARATOR

ALK (automated lamellar keratectomy)

Intervention Type PROCEDURE

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

Interventions

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ALK (automated lamellar keratectomy)

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

Intervention Type PROCEDURE

Mitomycin

mitomycin 0,02%, 30 seconds after ALK

Intervention Type DRUG

Other Intervention Names

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automated lamellar keratectomy with PTK automated lamellar keratectomy associated with PTK

Eligibility Criteria

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Inclusion Criteria

* Patient with bullous keratopathy symptomatic (with pain)

Exclusion Criteria

* herpetic endotelial disorders
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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UNIFESP

Principal Investigators

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Eliana D Gonçalves, MD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Other Identifiers

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0068/05

Identifier Type: -

Identifier Source: org_study_id