Automated Lamellar Keratectomy in Symptomatic Patients With Bullous Keratopathy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00654888

Acronym

ALKSBK

Enrollment

Registered

2008-04-09

Start date

2005-03-31

Completion date

2008-02-29

Last updated

2008-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Disease

Keywords

cataract extraction, surgery, corneal disease

Brief 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.

Detailed 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.

Interventions

PROCEDUREALK (automated lamellar keratectomy)

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

DRUGMitomycin

mitomycin 0,02%, 30 seconds after ALK

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

10 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patient with bullous keratopathy symptomatic (with pain)

Exclusion criteria

* herpetic endotelial disorders

Design outcomes

Primary

Measure	Time frame
Pain questionnaire	preoperative and postoperative 1,7,30,90,180 days and one year

Secondary

Measure	Time frame
biomicroscopy, esthesiometry, UBM pachymetry, impression cytology	preoperative, postoperative 1,7,30,90,180 days and one year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026