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OpenTrials
Completed

NCT Number: NCT00654888

Automated Lamellar Keratectomy 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.

Completed

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Key information

Conditions

Corneal Disease Corneal Diseases Eye Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with bullous keratopathy symptomatic (with pain)

Exclusion criteria

  • herpetic endotelial disorders

Treatment and study plan

ALK (automated lamellar keratectomy)

Procedure

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

Other names: automated lamellar keratectomy with PTK

Mitomycin

Drug

mitomycin 0,02%, 30 seconds after ALK

Other names: automated lamellar keratectomy associated with PTK

Primary outcomes

  1. Pain questionnaire

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

Secondary outcomes

  1. biomicroscopy, esthesiometry, UBM pachymetry, impression cytology

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

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Acronym: ALKSBK

Important dates

Study start
2005
Primary completion
2006
Study completion
2008
First posted
Apr 9, 2008
Registry last updated
Apr 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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